Pennsylvania Patient Safety Advisory Data Snapshot: Maternal Complications Analysts for the Pennsylvania Patient Safety Authority queried the Authority’s reporting system database for Table 1. Maternal Complications Reported maternal complications of pregnancy and childbirth. by Event Type, June 2004 through Search criteria included either (1) the event types August 2009* for maternal complications or (2) events in obstetric, EVENT TYPE TOTAL PERCENTAGE labor and delivery, and operating room venues with Maternal Complication mention of “mother” or “maternal” in the narratives. The analysts limited the search to Serious Events Death 20 7.8% (reporting patient harm) among female patients Unplanned transfer to intensive 15 5.9% 15 years old and older from the beginning of event care unit reporting (officially June 28, 2004) through August Uterine rupture 17 6.6% 31, 2009. Neonatal complications were excluded. Unanticipated blood transfusion 118 46.1% (adding 97 other significant The search resulted in the identification of 256 complications needing reports of maternal complications causing harm to treatment for bleeding) the mother. The ages of the mothers ranged from Pulmonary embolism 2 0.8% 16 to 47. For the 203 reports in which the method Seizure (adding 2 other central 8 3.1% of delivery was mentioned, 99 deliveries were vaginal nervous system complications) and 104 were ultimately by cesarean section. Infection 17 6.6% Table 1 lists the reports by event type. Some events Laceration of the birth canal 22 8.6% have been reclassified by the analysts for consistency Neuropathy 6 2.3% in reporting aggregate figures. Laceration of adjacent organ 5 2% during cesarean section Deaths Wound dehiscence 5 2% Twenty mothers died, including three with intra- Retained placenta 4 1.6% uterine fetal demise. Four of the deaths were due Retained object 3 1.2% to amniotic fluid emboli. Others were associated Skeletal injury 2 0.8% with Group A streptococcus infection, postpartum Spinal headache 2 0.8% bleeding, pulmonary embolus, uterine rupture, cerebrovascular thrombosis, and seizure; two of the Unattended delivery 2 0.8% patients had hysterectomies for postpartum bleeding Inadequate postoperative pain 1 0.4% (one died of a pulmonary embolus). Half of all the management deaths were attributed to cardiac and/or pulmonary Inversion of the uterus 1 0.4% failure not otherwise specified. Reaction from known latex 1 0.4% allergy Unplanned Transfers to Intensive Care Units Spontaneous rupture of the 1 0.4% (or Other Higher Levels of Care) liver Unplanned cesarean section in Five patients had cardiac and/or respiratory arrests, 1 0.4% mid-delivery of twins not due to blood loss or emboli, and survived; one Anesthesia Event was thought secondary to an adverse drug reaction to Ascending epidural 3 1.2% Pitocin®. Another seven patients had other cardiac and/or pulmonary complications not due to blood 256 100% loss or emboli. Two patients had HELLP syndrome, a * All reported as “complications of procedures/treatments/tests.” complication of pre-eclampsia characterized by hemo- lytic anemia, elevated liver enzymes, and low platelet counts, without further complications. One patient uterine abnormality. One more ruptured during a dila- was transferred to the intensive care unit postopera- tion and curettage procedure for a miscarriage. tively, without any reasons given. Unanticipated Blood Transfusions, Plus Other Uterine Ruptures Complications Causing Significant Bleeding Fifteen patients ruptured their uteri during labor or Postpartum bleeding was, by far, the most com- delivery and survived. Six patients were attempting vag- monly reported maternal complication (46% of all inal births after cesarean sections (VBAC); two (33%) the reports), with 118 patients having significant were reported to have needed hysterectomies. Four bleeding requiring treatment, for reasons other than of the other nine patients surviving uterine ruptures uterine rupture, and surviving. The causes of bleed- during labor and delivery were also reported to have ing included uterine atony, placental complications, needed hysterectomies (40% including the death). One lacerations, hematomas, postoperative bleeding, and other patient ruptured in midpregnancy because of a coagulopathies. One report involved bleeding from Page 26 REPRINTED ARTICLE - ©2009 Pennsylvania Patient Safety Authority Vol. 6, Suppl. 1—December 16, 2009 Pennsylvania Patient Safety Advisory perforation of the uterine wall during insertion of a a complication of a cesarean section done for one Foley catheter. Hysterectomies were reported to be of the patients with bleeding discussed above. needed to control the bleeding in 36 of these survi- Five patients had wound dehiscences after cesarean vors, plus the 2 patients who died (discussed above), sections. and 1 survivor whose most significant problem was a subdural hematoma secondary to her diffuse intravas- Four patients had retained placentas, apparently cular coagulation (DIC) (discussed below). uncomplicated by bleeding or infection. Three patients had retained objects. Two patients Pulmonary Emboli had vaginal sponges left after vaginal deliveries and Two patients survived pulmonary emboli. One had a repairs of vaginal lacerations. One patient had a vaginal delivery and the other had a cesarean section. needle fragment that needed finding at the end of a cesarean section. Seizures, Plus Other Central Nervous System Complications Two patients had skeletal injuries. One had a fractured rib and the other had a symptomatic Six patients were reported to have seizures and pubic separation. survived. None of the seizures were a pre-existing comorbidity. Two other patients were added to this Two patients had spinal headaches. Three ascend- group by the analysts. Both had subdural hematomas; ing epidurals were also reported as anesthesia one was secondary to disseminated intravascular coag- events. ulation severe enough to necessitate a hysterectomy. Two patients were delivered by the labor and deliv- ery nurse; their primary providers were not present. Primary Infections Other complications included inadequate postpar- One patient developed septic shock. Three patients tum analgesia, inversion of the uterus, an allergic had chorioamnionitis. Four patients developed nec- reaction to latex in a patient with a known allergy, rotizing fasciitis of their wounds; three developed an a spontaneous rupture of the liver in a patient intra-abdominal abscess; and five patients developed with HELLP syndrome, and conversion to an wound infections after cesarean sections. One other unplanned cesarean section after the successful patient developed an infection of her episiotomy. vaginal delivery of a first twin. Other Complications Hysterectomies Twenty-two patients had lacerations of the birth Forty-five patients were reported to have needed canal that did not present primarily as bleeding hysterectomies: 2 who died following postpartum problems. All were related to vaginal deliveries. bleeding as noted above, 6 who survived uterine rup- The lacerations were predominantly third- and tures, 36 who survived postpartum bleeding, and 1 fourth-degree perineal lacerations, one of which survivor whose DIC was complicated by a subdural required a diverting colostomy. Other sites hematoma. One of the patients, less than 30 years described were the vagina, the peri-urethral area, old, had a bilateral salpingo-oophorectomy as well. and the cervix. The mortality rate for the hysterectomies reported in Six patients had neuropathies of their lower response to maternal complications was 4%. Hysterec- extremities. tomies were done for 6 of the 16 patients (38%) who Five patients had lacerations of adjacent organs ruptured their uteri during labor and delivery (15 who during cesarean sections that were reported as survived and 1 who died). Hysterectomies were done unanticipated complications; three were of the for 39 of the 121 patients (32%) with bleeding compli- bowel and two were of the bladder. Another two cations (including the 2 who died, as noted above, and bladder lacerations were reported as complications the 1 whose most significant problem was a subdural of cesarean sections done for the uterine ruptures hematoma secondary to DIC). The mortality rate was mentioned above. Another bladder laceration, with 5% for the hysterectomies done as a potentially lifesav- concomitant ureteral obstruction, was reported as ing procedure for postpartum hemorrhage. Vol. 6, Suppl. 1—December 16, 2009 REPRINTED ARTICLE - ©2009 Pennsylvania Patient Safety Authority Page 27 PENNSYLVANIA PATIENT SAFETY ADVISORY This article is reprinted from the Pennsylvania Patient Safety Advisory, Vol. 6, Suppl. 1—December 16, 2009. The Advisory is a publication of the Pennsylvania Patient Safety Authority, produced by ECRI Institute and ISMP under contract to the Authority. Copyright 2009 by the Pennsyl- vania Patient Safety Authority. This publication may be reprinted and distributed without restriction, provided it is printed or distributed in its entirety and without alteration. Individual articles may be reprinted in their entirety and with- out alteration provided the source is clearly attributed. This publication is disseminated via e-mail. To subscribe, go to https://www.papsrs.state.pa.us/ Workflow/MailingListAddition.aspx. To see other articles or issues of the Advisory, visit our Web site at http://www.patientsafetyauthority.org. Click on “Patient Safety Advisories” in the left-hand menu bar. THE PENNSYLVANIA PATIENT SAFETY AUTHORITY AND ITS CONTRACTORS The Pennsylvania Patient Safety Authority is an independent state agency created by Act 13 of 2002, the Medical Care Availability and Reduction of Error (“Mcare”) Act. Consistent with Act 13, ECRI Institute, as contractor for the Authority, is issuing this publication to advise medical facilities of immediate changes that can be instituted to reduce Serious Events and Incidents. For more information about the Pennsylvania Patient Safety Authority, see the Authority’s Web An Independent Agency of the Commonwealth of Pennsylvania site at http://www.patientsafetyauthority.org. ECRI Institute, a nonprofit organization, dedicates itself to bringing the discipline of applied scientific research in healthcare to uncover the best approaches to improving patient care. As pioneers in this science for nearly 40 years, ECRI Institute marries experience and independence with the objectivity of evidence-based research. More than 5,000 healthcare organizations worldwide rely on ECRI Institute’s expertise in patient safety improvement, risk and quality management, and healthcare processes, devices, procedures and drug technology. The Institute for Safe Medication Practices (ISMP) is an independent, nonprofit organization dedicated solely to medication error prevention and safe medication use. ISMP provides recommendations for the safe use of medications to the healthcare community including healthcare professionals, government agencies, accrediting organizations, and consumers. ISMP’s efforts are built on a nonpunitive approach and systems-based solutions.