F RO M T H E DATA B A S E Data Snapshot: Maternal Serious Events Susan C. Wallace, MPH, CRPRM INTRODUCTION Patient Safety Analyst Pennsylvania Patient Safety Authority A request from the Health Care Improvement Foundation (HCIF) for an update to a 2009 Pennsylvania Patient Safety Advisory data snapshot on maternal events led Pennsylvania Patient Safety Authority analysts to query the Pennsylvania Patient Safety Reporting System (PA-PSRS) database for maternal events (see also the Letter to the Editor in this issue). Analysts limited the search to Serious Events over a five-year period, resulting in an examination of 537 events. METHODS Analysts searched the database to identify Serious Events among female patients 12 to 49 years of age which were reported from January 1, 2011, through December 31, 2015. Events were identified satisfying any of the following search criteria: (1) event types that include maternal complication of procedure/treatment/test, (2) events reported from care areas related to obstetrics, labor and delivery, and operating room venues, (3) event descriptions related to delivery with search terms including placenta, maternal, and C-section with variations (e.g., CS), or (4) event descriptions with the following terms in combination with care areas (i.e., ob*, gyn*, labor[^a]*, post-partum*): bled, bleed, blood pressure, “clot,” dehis*, deliver, edema, em*, embolism, hematom*, hemm*, hemor*, high bp, htn, hypertens*, hypotens*, intubat*, lacera*, low bp, mom, mother, neurop*, pe, pph, pulm*, seroma, skelet*, transfus*. The wildcard character (*) ensured that the search also yielded events containing other word forms (e.g., pulm* returns both pulmo- nary and pulmonologist). RESULTS The query identified 685 event reports; 148 were excluded because they were unrelated to the scope of the query (e.g., a hysterectomy in a non-pregnant woman) or addressed a non-maternal complication event (e.g., fall), leaving 537 events for analysis. Examination of event descriptions revealed 34 categories of possible harm or treatment (see Table). Some events could be assigned to more than one category, resulting in a total of 976 entries. The top five event categories in order of frequency were (1) unan- ticipated blood transfusion, (2) laceration of the birth canal, (3) unplanned transfer to the intensive care unit, (4) postpartum hemorrhage, and (5) bladder injuries. These categories were not necessarily independent (e.g., a patient may have required an unan- ticipated blood transfusion and an unplanned transfer to the intensive care unit). Of the 537 events analyzed, 11 (2.0%) resulted in death. Unanticipated Blood Transfusion Unanticipated blood transfusion was cited in 121 of the events and was the most com- monly reported maternal complication. Reasons cited for bleeding included lacerations, uterine ruptures, uterine dehiscence, intra-abdominal hemorrhages, and hematomas. Examples are as follows:* Patient with previous C-section, attempting vaginal delivery; [fetus] had variable decelerations despite corrective action. Decision made to take patient for C-section. On entry into the abdomen in the operating room, a uterine dehiscence was identified and * The details of the PA-PSRS event narratives in this article have been modified to preserve confidentiality. (continued on page 165) Vol. 13, No. 4—December 2016 Pennsylvania Patient Safety Advisory Page 163 ©2016 Pennsylvania Patient Safety Authority F RO M T H E DATA B A S E Table. Maternal Serious Events Reported by Event Category, 2011 through 2015* CATEGORIES NUMBER OF EVENTS PERCENTAGE Unanticipated blood transfusion 121 12.4 Laceration of the birth canal 99 10.1 Unplanned transfer to intensive care unit 76 7.8 Postpartum hemorrhage 74 7.6 Bladder injury 66 6.8 Other events requiring treatment for bleeding complications (e.g., uterine artery bleeding, blood clots) 65 6.7 Hysterectomy 59 6.0 Hematoma 57 5.8 Unplanned return to operating room 54 5.5 Retained placental products 50 5.1 Retained surgical item (e.g., retained sponge) 27 2.8 Uterine atony 27 2.8 Anesthesia event (e.g., spinal block headache) 24 2.5 Cardiac condition (e.g., cardiomyopathy, tachycardia) 19 1.9 Uterine rupture 18 1.8 Preeclampsia 16 1.6 Bowel injury 13 1.3 Infection 13 1.3 Placental abruption 13 1.3 Death 11 1.1 Pulmonary issues (e.g., embolism, respiratory depression) 11 1.1 Unplanned transfer to tertiary care facility 11 1.1 Wound dehiscence 10 1.0 Medication event (e.g., wrong patient, wrong drug) 7 0.7 Uterine inversion 7 0.7 Seizure 6 0.6 Skeletal/Muscular injury 5 0.5 Neuropathy 4 0.4 Placenta previa 3 0.3 Seroma 3 0.3 Amniotic fluid embolism 2 0.2 Thermal burn 2 0.2 Unattended delivery 2 0.2 Hernia rupture 1 0.1 Total 976 100 * Some reports described more than one maternal complication event category. Page 164 Pennsylvania Patient Safety Advisory Vol. 13, No. 4—December 2016 ©2016 Pennsylvania Patient Safety Authority (continued from page 163) and/or respiratory arrests, HELLP syn- Examples are as follows: repaired. Patient required PRBC drome,* uterine atony, uterine rupture During a C-Section that was compli- [packed red blood cells]. and post-partum hemorrhage. cated by placenta previa, a placenta Physician performed rupture of mem- Examples are as follows: accreta was discovered and trauma branes. A large amount of bright, Patient having C-section. Patient is obese to the bladder occurred. Urologist red blood noted. STAT C-section with maternal weight [of nearly 160 kg]. assisted in bladder repair. performed. Infant delivered under [Patient] was given spinal, and after Patient experienced an incidental general anesthesia. Mother with low patient positioned, she complained of bladder laceration during a cesarean hemoglobin and hematocrit, received difficulty breathing. Oxygen saturation section requiring urology surgeon two units of packed red blood cells. decreased after a minute, and the patient intra-operative consultation and was bagged. The patient was transferred suture closure of bladder. Patient rang call bell to say that she to an intensive care unit. was bleeding. Patient in pool of blood with large clots. Approximately 600 cc Physician in to see patient with previ- Deaths blood noted. Physician notified. ous C-section; attempting vaginal Eleven maternal deaths were reported, Pitocin, Methergine and Cytotec delivery, and patient was 8 centime- including one with intra-uterine fetal administered. Uterine massage by phy- ters on vaginal exam. Blood noted in death. Deaths were associated with dis- sician. Bleeding stopping and fundus Foley tubing and with exam. Patient seminated intravascular coagulopathy, firm. Patient received 2 units of blood. then moved to the operating room for amniotic fluid emboli, gram negative bac- delivery by C-section. During surgery, teremia, and chronic myocarditis. Three Laceration of the Birth Canal it was noted that uterus and bladder of the patients had hysterectomies to Birth canal laceration was cited in 99 of had ruptured. Urologist consulted manage postpartum bleeding. Three event to repair bladder. Patient was trans- reports did not specify a cause of death. the events. Third- and fourth-degree peri- ferred to the intensive care unit. neal lacerations, or tears, were the most commonly associated condition; seven Limitations of these reports cited newborns weighing Postpartum Hemorrhage Analysis of Serious Events is limited Postpartum hemorrhage was cited in 74 by the information reported through more than 8 lb. events. Reasons for hemorrhage included PA-PSRS, including the event descrip- Examples are as follows: retained placenta and uterine atony. tions. As with all reporting systems, the Patient with excessive vaginal bleed- Treatment included medications, dilation type and number of reports collected ing following delivery. Patient to and curettage, and hysterectomy. depend on the degree to which facility operating room for vaginal exam and Examples are as follows: reporting is accurate and complete. vaginal laceration repair. Patient had a primary C-section. Arrived in spontaneous labor, and Returned to operating room for CONCLUSION pushed for three hours. The physician postpartum hemorrhage with uterine Analysis of PA-PSRS data revealed that assisted with fetal descent by vacuum atony. Exam performed under anes- the most common maternal Serious application. After delivery of the thesia and balloon catheter placed. Events reported are laceration of the head, the anterior shoulder got stuck. Patient tolerated procedure well. birth canal, postpartum hemorrhage, The patient had a 3rd degree lacera- and bladder laceration. Life-threatening tion and was taken to the operating Patient taken back to main operating room after C-section due to change events can occur during and after delivery room for repair under spinal. and, rarely, can contribute to maternal in patient condition. Patient had exploratory laparoscopy with ligation and intra-uterine fetal death. Reporting Unplanned Transfer to the detailed circumstances related to maternal Intensive Care Unit of the right uterine artery to control hemorrhage. Serious Events can contribute to a better Unplanned transfer to the intensive care understanding of harm prevention and unit was cited in 76 events. Reasons for improved patient safety. Bladder Injury the unplanned transfers included cardiac Bladder injury was cited in 66 events. Bladder laceration was the most com- * HELLP is an abbreviation for the three main monly reported bladder injury. Treatment features of the syndrome: Hemolysis, Elevated included repair by a urologist. Liver enzymes and Low Platelet count. Vol. 13, No. 4—December 2016 Pennsylvania Patient Safety Advisory Page 165 ©2016 Pennsylvania Patient Safety Authority PENNSYLVANIA PATIENT SAFETY ADVISORY This article is reprinted from the Pennsylvania Patient Safety Advisory, Vol. 13, No. 4—December 2016. The Advisory is a publication of the Pennsylvania Patient Safety Authority, produced by ECRI Institute and ISMP under contract to the Authority. Copyright 2016 by the Pennsylvania 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 without alteration provided the source is clearly attributed. 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