FETAL PILLOW, BOX OF 6
Report
- Report Number
- 1216677-2021-00240
- Event Type
- Death
- Date Received
- October 25, 2021
- Date of Event
- September 25, 2021
- Report Date
- January 18, 2022
- Manufacturer
- COOPERSURGICAL INC.
- Product Code
- PWB
- PMA / PMN Number
- DEN150053
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
FOLLOW UP # 2. 01/17/2022. THE INVESTIGATION ANALYSIS AND FINDINGS ARE DETAILED AS FOLLOWS : DISTRIBUTION HISTORY THE COMPLAINT PRODUCT WAS PURCHASED FROM SUPPLIER ; SAFE OBSTETRIC SYSTEMS LTD; AND WAS SOLD BY COOPERSURGICAL TO THE CUSTOMER. THE LOT NUMBER OF THE COMPLAINANT PRODUCT WAS NOT PROVIDED. HOWEVER, SHIPPING HISTORY SHOWS PRODUCT FROM LOT 20790 (IN JUNE/JULY 2021) AND LOT 20587 (IN AUGUST/SEPTEMBER 2021) WERE THE ONLY LOTS SHIPPED TO THIS CUSTOMER. MANUFACTURING RECORD REVIEW A REVIEW OF FINISHED GOODS INVENTORY FOUND LOT NUMBER 20587 AND 20790 HAVE BEEN DEPLETED. BATCH AND TESTING RECORDS FOR BOTH LOT NUMBERS (20790 AND 20587) WERE REVIEWED, AND THE PRODUCT MET FINAL TESTING REQUIREMENTS BEFORE RELEASE TO COOPERSURGICAL. INCOMING INSPECTION REVIEW NON-ROUT INSP-21-06-23-001 WAS REVIEWED FOR LOT 20587 ONLY NOTING THERE WERE SOME DAMAGED BOXES, THESE BOXES WERE SCRAPPED. ALSO, IT WAS NOTED THE CERTIFICATE OF CONFORMANCE WAS MISSING PER PRINT AND VARIANCE VAR210065 REV C ACCEPTED THIS PRODUCT DUE TO INTERCOMPANY TRANSFER. NON-ROUT INSP-21-04-30-001 WAS REVIEWED FOR LOT 20790, AND IT WAS NOTED THE CERTIFICATE OF CONFORMANCE WAS MISSING PER PRINT, AND VARIANCE VAR210065 REV B ACCEPTED THIS PRODUCT DUE TO INTERCOMPANY TRANSFER. A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED TWO OTHER POSTERIOR UTERINE RUPTURE COMPLAINTS , FROM DIFFERENT FACILITIES. INVESTIGATION INTO ONE OF THOSE COMPLAINTS INVOLVED LOT NUMBER 20587. A VISUAL INSPECTION OF A SAMPLE OF THIS LOT FROM FINISHED GOODS DID NOT REVEAL ANY DISCREPANCIES. THIS CASE WAS OF A TWIN PREGNANCY, AND THE IFU DOES STATE THE SAFETY AND EFFECTIVENESS OF FETAL PILLOW HAS NOT BEEN ESTABLISHED IN MULTIPLE GESTATION . IN THE INVESTIGATION OF THE SECOND COMPLAINT THE PRODUCT WAS OF UNKNOWN LOT AND NO SAMPLE RETURNED FOR EVALUATION , AS SUCH ROOT CAUSE WAS UNABLE TO BE DETERMINED. FUNCTIONAL EVALUATION PHYSICAL EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE CUSTOMER DOES NOT HAVE THE PRODUCT FOR RETURN. BASED ON INFORMATION RECEIVED VIA CONFERENCE CALL WITH THE HEALTHCARE PROVIDER ON (B)(6) 2021 , IT WAS FOUND THAT THE PRODUCT WAS PLACED HOWEVER IT WAS NEVER INFLATED. PER IFU STEP 4, "A TOTAL OF 180CC OF SALINE IS REQUIRED TO PRODUCE THE DESIRED ELEVATION." THERE WAS NO REPORTED MALFUNCTION OF THE PRODUCT. IT SHOULD ALSO BE NOTED IN THIS CASE THE PILLOW WAS USED AND THE MOTHER HAD A PRIOR C-SECTION . THE IFU WARNING IN THIS REGARD STATES "THE SAFETY AND EFFECTIVENESS OF FETAL PILLOW HAS NOT BEEN ESTABLISHED IN THE FOLLOWING : 1. IN WOMEN WHO HAVE HAD A PREVIOUS CAESARIAN DELIVERY" RISK MANAGEMENT FILE REVIEW: THE RISK MANAGEMENT FILE, WHICH WAS AS TRANSFERRED (UNCHANGED) TO COOPERSURGICAL, WAS REVIEWED AND THE RISKS WERE APPROPRIATELY EVALUATED. THERE WERE NO HAZARDS RATED HIGHER THAN A TWO (2) ON A SCALE OF THE 1 TO 5 (WITH 5 BEING MOST SEVERE). ROOT CAUSE: NO DEFINITIVE ROOT CAUSE COULD BE RELIABLY DETERMINED AT THIS TIME. *CORRECTION AND/OR CORRECTIVE ACTION: NO CORRECTIVE ACTION IS NECESSARY AS NO DEFINITIVE ROOT CAUSE COULD BE RELIABLY DETERMINED. FOLLOW UP # 1 10/26/2021 H10: ADDITIONAL INFORMATION RECEIVED. ADDITIOINAL INFORMATION FOR A4 : 3.415 KG. MOTHER: GRAVIDA 2 PARA 1 ADDITIONAL INFORMATION WAS RECEIVED 10/26/2021 REGARDING THE USE OF THE FETAL PILLOW. THE CUSTOMER REPORTED THAT IN THE OPERATIVE NOTE IT WAS DOCUMENTED THAT A PHYSICIAN REMOVED THE FETAL PILLOW. THE LOT NUMBER WAS NOT DOCUMENTED. WHEN ASKED ABOUT RETURNING THE DEVICE THE CUSTOMER STATED THEY ASSUMED THE FETAL PILLOW WAS DISCARDED. FURTHER DOCUMENTATION SHOWED THE PILLOW WAS REMOVED INTACT. IT WAS CONFIRMED THAT AT THE TIME OF THE C-SECTION THE MOTHER WAS DILATED 10 CM, 100% EFFACED AND AT 0 STATION AT 0016 ON (B)(6) 2021. THE PREOPERATIVE DIAGNOSES WERE PRIOR LOW TRANSVERSE CESAREAN SECTION, INTRAUTERINE PREGNANCY AT 39+5 WEEKS GESTATIONAL AGE, AND FETAL INTOLERANCE OF LABOR. THE PROCEDURES FOR THE MOTHER INCLUDED A REPEAT LOW TRANSVERSE CESAREAN SECTION, REPAIR OF RIGHT POSTERIOR UTERINE RUPTURE, LEFT OVARIAN CYSTECTOMY, AND LYSIS OF ADHESIONS. THE POSTOPERATIVE DIAGNOSIS WERE PRIOR LOW TRANSVERSE CESAREAN SECTION, INTRAUTERINE PREGNANCY AT 39+5 WEEKS GESTATIONAL AGE, FETAL INTOLERANCE OF LABOR, AND POSTERIOR UTERINE RUPTURE. MATERNAL PROCEDURE DOCUMENTATION SHOWED THE FOLLOWING: "AFTER ASSURING INFORMED CONSENT, THE PATIENT WAS TAKEN TO THE OPERATING ROOM WHERE EPIDURAL ANESTHESIA WAS DOSED FOR CESAREAN SECTION. FETAL HEART TONES WERE AUSCULTATED IN THE 130S BY A FETAL SCALP ELECTRODE. IT WAS ALSO STATED THAT "SHE DID RECEIVE ANCEF 3 G PREOPERATIVELY AS WELL AS AZITHROMYCIN 500 MG PREOPERATIVELY. PRIOR TO THE INITIAL INCISION, GENTAMICIN WAS ALSO ORDERED, BUT WAS NOT GIVEN TO THE COMPLETION OF THE CASE." NEXT, A PFANNENSTIEL SKIN INCISION WAS MADE WITH A SCALPEL THROUGH A PREVIOUS SCAR AND CARRIED DOWN TO THE LEVEL OF THE FASCIA. IT WAS NOTED INFERIOR TO THE FASCIA WAS NOTED A DENSE RECTUS SHEATH AND THE RECTUS MUSCLES WERE EXTREMELY ATTENUATED AND COULD NOT BE APPRECIATED. THERE WAS A GUSH OF BLOOD AND FLUID NOTED UPON ENTERING THE PERITONEAL CAVITY. NEXT, THE LOWER UTERINE SEGMENT WAS IDENTIFIED AND NOTED TO BE INTACT AND THE INCISION WAS MADE TRANSVERSELY WITH A SCALPEL. IT WAS EXTENDED BILATERALLY BLUNTLY AND THE INFANT'S HEAD WAS ELEVATED TO THE INCISION AND DELIVERED. THE CORD WAS CLAMPED AND CUT AND IMMEDIATELY HANDED TO THE AWAITING NEONATAL STAFF AND THE NEONATOLOGIST WAS CALLED FOR IMMEDIATELY. NEXT, THE PLACENTA WAS DELIVERED MANUALLY INTACT AND SENT TO PATHOLOGY. A DEFECT WAS NOTED IN THE POSTERIOR WALL OF THE UTERUS. UPON FURTHER EXAMINATION, THE DEFECT WAS APPROXIMATELY 10 CM IN LENGTH FROM THE MID BODY OF THE POSTERIOR UTERINE WALL ON THE RIGHT DIVING DOWN TOWARDS THE VAGINA. THIS DEFECT WAS CLOSED WITH A RUNNING LOCKING SUTURE OF 0 MONOCRYL IN 2 LAYERS. THE HYSTEROTOMY WAS CLOSED IN A RUNNING LOCKING SUTURE OF 0 LOOPED PDS. ON THE LEFT SIDE, THERE WAS A LACERATION OF THE ASCENDING UTERINE VEIN AND THIS WAS CLAMPED AND LIGATED WITH 0 VICRYL UNTIL IT WAS HEMOSTATIC. A LEFT OVARIAN CYST WAS IDENTIFIED AND A CSYECTOMY WAS PERFORMED BY A SECOND PHYSICIAN. THE ABDOMINAL INCISION WAS CLOSED IN STANDARD FASHION. THE MOTHER WAS ADMITTED TO THE ANTEPARTUM UNIT FOR CONTINUED CARE AND PER HER REQUEST SHE WAS DISCHARGED HOME IN STABLE CONDITION ON POSTOPERATIVE DAY NUMBER TWO ((B)(6) 2021). IN THE NEWBORN FINDING INFORMATION, IT WAS FURTHER REPORTED THAT THE BABY WAS BORN ON (B)(6) 2021 AT 0331 VIA A REPEAT LOW TRANSVERSE CESARIAN SECTION THAT FOLLOWED A FAILED TRIAL OF LABOR AFTER C-SECTION SECONDARY TO A POSTERIOR UTERINE RUPTURE. IT WAS REPORTED THAT THE BABY HAD APGAR SCORES OF 0,0,0,0,2 AT ONE, FIVE, TEN, FIFTEEN, AND TWENTY MINUTES OF LIFE RESPECTIVELY. HE WAS DELIVERED FROM A VERTEX PRESENTATION AND WAS LIMP WITHOUT RESPIRATORY EFFORT WHEN HE WAS PASSED TO THE RESPIRATORY STAFF. FURTHER NEWBORN INFORMATION SHOWED THAT NEONATAL RESUSCITATIVE EFFORTS WERE INITIATED; FULL MEDICAL RESUSCITATION WAS PERFORMED IN THE DELIVERY ROOM. FULL EFFORTS INCLUDED INTUBATION. COORDINATED POSITIVE PRESSURE (PPV) AND CHEST COMPRESSIONS PROVIDED WITHOUT HEART TOMES. NNP ARRIVED AT 4 MINUTES AND MD ARRIVED AT APPROXIMATELY 8 MINUTES. FIRST DOSE OF ETT EPI PROVIDED ~9 MINUTES OF LIFE. NO HEART TONES NOTED. PPV AND CHEST COMPRESSIONS CONTINUED. SECOND DOSE OF ETT EPI PROVIDED WITHOUT HEART TONES. UMBILICAL VENOUS CATHETER (UVC) PLACED AND WAS USED TO PROVIDE THE THIRD DOSE OF EPI AND A NORMAL SALINE (NS) BOLUS (12 MINUTES OF LIFE) WITH NO HEART TONES NOTED. FOURTH EPI DOSE AND SECOND NS BOLUS PROVIDED (15 MINUTES OF LIFE) AND FAINT HEART TONES NOTED. CHEST COMPRESSIONS CONTINUED. AT 17 MINUTES OF LIFE BABY NOTED TO HAVE HEART TONES >100 BPM. THE BABY WAS ADMITTED TO THE NICU AND WHOLE BODY COOLING WAS INITIATED. LIFE SUPPORT WAS WITHDRAWN BY THE FAMILY LESS THAN 24 HOURS AFTER DELIVERY. THE DATE OF DEATH WAS (B)(6) 2021 AT 1840." ACCORDING TO THE CUSTOMER THE BABY'S CAUSE OF DEATH ON THE DEATH CERTIFICATE WAS "RESPIRATORY FAILURE RELATED TO SEVER HYPOXIC ISCHEMIC ENCEPHALOPATHY". ON 11/23/2021 A DISCUSSION WITH THE PHYSICIAN PROVIDED THE FOLLOWING ADDITIONAL INFORMATION. THE MOTHER WAS MORBIDLY OBESE WITH A BMI OF 40. HER PRIOR CESAREAN SECTION WAS LOW TRANSVERSE FOR FETAL DISTRESS. SHE REPORTED THAT THE MOM HAD A SPONTANEOUS LABOR WUGMENTED WITH PITOCIN AND AN ARTIFICIAL RUPTURE OF THE MEMBRANES WITH CLEAR FLUID. AN INTRAUTERINE PRESSURE (IUCP) CATHETER WAS PLACED AND NO AMNIO INFUSION WAS PERFORMED. A FETAL SCALP ELECTRODE WAS PLACED AND THERE WAS A FETAL HEART DECELERATION NOTED BY THE NURSE. THE PHYSICIAN DID NOT HAVE THE INFORMATION TO PROVIDE THE ANSWERS FOR HOW LONG WAS THE DECELERATION AND WHAT WAS THE HEART RATE. AT THE TIME OF DECISION FOR THE CESARIAN SECTION THE FETAL HEART RATE HAD RECOVERED BUT HAD REDUCED VARIABILITY. IT WAS FURTHER REPORTED THAT THE MOTHER PUSHED FOR 2 HOURS - VERTEX, FULLY DILATED BUT THE POSITION OF THE BABY WAS NOT RECALLED. ONCE THE DECISION WAS MADE FOR THE CESAREAN SECTION THERE WAS DIFFICULTY IN DOSING THE EPIDURAL. THE SCALP ELECTRODE AND IUCP WERE REMOVED. SHE STATED THE FETAL PILLOW WAS INSERTED BUT NEVER INFLATED. THE POSTERIOR RUPTURE WAS NOT NOTED UNTIL THE END OF THE PERITONEAL PORTION OF THE PROCEDURE. SHE FURTHER REPORTED DURING THE DISCUSSION THAT IT EXTENDED ON THE RIGHT FROM THE MID-FUNDAL POSITION 8CM TO THE CERVICAL-VAGINAL JUNCTION. SHE STATED ANOTHER PHYSICIAN PERFORMED A CYSTOSCOPY AT THE CONCLUSION OF THE PROCEDURE (URETERS WERE INTACT) AND REMOVED THE INTACT FETAL PILLOW. THE BABIES BLOOD GASES WERE REPORTED AS: ATRIAL CORD GAS: 6.86 BD/BE -23. VENOUS CORD GAS: 7.04 BD/BE -13. B2 - CORRECTED DATE OF BABY'S DEATH TO (B)(6) 2021.
H10: ADDITIONAL INFORMATION RECEIVED 10/26/2021. ADDITIOINAL INFORMATION FOR A4 : 3.415 KG MOTHER: GRAVIDA 2 PARA 1 ADDITIONAL INFORMATION WAS RECEIVED 10/26/2021 REGARDING THE USE OF THE FETAL PILLOW. THE CUSTOMER REPORTED THAT IN THE OPERATIVE NOTE IT WAS DOCUMENTED THAT A PHYSICIAN REMOVED THE FETAL PILLOW. THE LOT NUMBER WAS NOT DOCUMENTED. WHEN ASKED ABOUT RETURNING THE DEVICE THE CUSTOMER STATED THEY ASSUMED THE FETAL PILLOW WAS DISCARDED. FURTHER DOCUMENTATION SHOWED THE PILLOW WAS REMOVED INTACT. IT WAS CONFIRMED THAT AT THE TIME OF THE C-SECTION THE MOTHER WAS DILATED 10 CM, 100% EFFACED AND AT 0 STATION AT 0016 ON 9/25/2021. THE PREOPERATIVE DIAGNOSES WERE PRIOR LOW TRANSVERSE CESAREAN SECTION, INTRAUTERINE PREGNANCY AT 39+5 WEEKS GESTATIONAL AGE, AND FETAL INTOLERANCE OF LABOR. THE PROCEDURES FOR THE MOTHER INCLUDED A REPEAT LOW TRANSVERSE CESAREAN SECTION, REPAIR OF RIGHT POSTERIOR UTERINE RUPTURE, LEFT OVARIAN CYSTECTOMY, AND LYSIS OF ADHESIONS. THE POSTOPERATIVE DIAGNOSIS WERE PRIOR LOW TRANSVERSE CESAREAN SECTION, INTRAUTERINE PREGNANCY AT 39+5 WEEKS GESTATIONAL AGE, FETAL INTOLERANCE OF LABOR, AND POSTERIOR UTERINE RUPTURE. MATERNAL PROCEDURE DOCUMENTATION SHOWED THE FOLLOWING: "AFTER ASSURING INFORMED CONSENT, THE PATIENT WAS TAKEN TO THE OPERATING ROOM WHERE EPIDURAL ANESTHESIA WAS DOSED FOR CESAREAN SECTION. FETAL HEART TONES WERE AUSCULTATED IN THE 130S BY A FETAL SCALP ELECTRODE. IT WAS ALSO STATED THAT "SHE DID RECEIVE ANCEF 3 G PREOPERATIVELY AS WELL AS AZITHROMYCIN 500 MG PREOPERATIVELY. PRIOR TO THE INITIAL INCISION, GENTAMICIN WAS ALSO ORDERED, BUT WAS NOT GIVEN TO THE COMPLETION OF THE CASE." NEXT, A PFANNENSTIEL SKIN INCISION WAS MADE WITH A SCALPEL THROUGH A PREVIOUS SCAR AND CARRIED DOWN TO THE LEVEL OF THE FASCIA. IT WAS NOTED INFERIOR TO THE FASCIA WAS NOTED A DENSE RECTUS SHEATH AND THE RECTUS MUSCLES WERE EXTREMELY ATTENUATED AND COULD NOT BE APPRECIATED. THERE WAS A GUSH OF BLOOD AND FLUID NOTED UPON ENTERING THE PERITONEAL CAVITY. NEXT, THE LOWER UTERINE SEGMENT WAS IDENTIFIED AND NOTED TO BE INTACT AND THE INCISION WAS MADE TRANSVERSELY WITH A SCALPEL. IT WAS EXTENDED BILATERALLY BLUNTLY AND THE INFANT'S HEAD WAS ELEVATED TO THE INCISION AND DELIVERED. THE CORD WAS CLAMPED AND CUT AND IMMEDIATELY HANDED TO THE AWAITING NEONATAL STAFF AND THE NEONATOLOGIST WAS CALLED FOR IMMEDIATELY. NEXT, THE PLACENTA WAS DELIVERED MANUALLY INTACT AND SENT TO PATHOLOGY. A DEFECT WAS NOTED IN THE POSTERIOR WALL OF THE UTERUS. UPON FURTHER EXAMINATION, THE DEFECT WAS APPROXIMATELY 10 CM IN LENGTH FROM THE MID BODY OF THE POSTERIOR UTERINE WALL ON THE RIGHT DIVING DOWN TOWARDS THE VAGINA. THIS DEFECT WAS CLOSED WITH A RUNNING LOCKING SUTURE OF 0 MONOCRYL IN 2 LAYERS. THE HYSTEROTOMY WAS CLOSED IN A RUNNING LOCKING SUTURE OF 0 LOOPED PDS. ON THE LEFT SIDE, THERE WAS A LACERATION OF THE ASCENDING UTERINE VEIN AND THIS WAS CLAMPED AND LIGATED WITH 0 VICRYL UNTIL IT WAS HEMOSTATIC. A LEFT OVARIAN CYST WAS IDENTIFIED AND A CSYECTOMY WAS PERFORMED BY A SECOND PHYSICIAN. THE ABDOMINAL INCISION WAS CLOSED IN STANDARD FASHION. THE MOTHER WAS ADMITTED TO THE ANTEPARTUM UNIT FOR CONTINUED CARE AND PER HER REQUEST SHE WAS DISCHARGED HOME IN STABLE CONDITION ON POSTOPERATIVE DAY NUMBER TWO (9/27/2021). IN THE NEWBORN FINDING INFORMATION, IT WAS FURTHER REPORTED THAT THE BABY WAS BORN ON 9/25/2021 AT 0331 VIA A REPEAT LOW TRANSVERSE CESARIAN SECTION THAT FOLLOWED A FAILED TRIAL OF LABOR AFTER C-SECTION SECONDARY TO A POSTERIOR UTERINE RUPTURE. IT WAS REPORTED THAT THE BABY HAD APGAR SCORES OF 0,0,0,0,2 AT ONE, FIVE, TEN, FIFTEEN, AND TWENTY MINUTES OF LIFE RESPECTIVELY. HE WAS DELIVERED FROM A VERTEX PRESENTATION AND WAS LIMP WITHOUT RESPIRATORY EFFORT WHEN HE WAS PASSED TO THE RESPIRATORY STAFF. FURTHER NEWBORN INFORMATION SHOWED THAT NEONATAL RESUSCITATIVE EFFORTS WERE INITIATED; FULL MEDICAL RESUSCITATION WAS PERFORMED IN THE DELIVERY ROOM. FULL EFFORTS INCLUDED INTUBATION. COORDINATED POSITIVE PRESSURE (PPV) AND CHEST COMPRESSIONS PROVIDED WITHOUT HEART TOMES. NNP ARRIVED AT 4 MINUTES AND MD ARRIVED AT APPROXIMATELY 8 MINUTES. FIRST DOSE OF ETT EPI PROVIDED ~9 MINUTES OF LIFE. NO HEART TONES NOTED. PPV AND CHEST COMPRESSIONS CONTINUED. SECOND DOSE OF ETT EPI PROVIDED WITHOUT HEART TONES. UMBILICAL VENOUS CATHETER (UVC) PLACED AND WAS USED TO PROVIDE THE THIRD DOSE OF EPI AND A NORMAL SALINE (NS) BOLUS (12 MINUTES OF LIFE) WITH NO HEART TONES NOTED. FOURTH EPI DOSE AND SECOND NS BOLUS PROVIDED (15 MINUTES OF LIFE) AND FAINT HEART TONES NOTED. CHEST COMPRESSIONS CONTINUED. AT 17 MINUTES OF LIFE BABY NOTED TO HAVE HEART TONES >100 BPM. THE BABY WAS ADMITTED TO THE NICU AND WHOLE BODY COOLING WAS INITIATED. LIFE SUPPORT WAS WITHDRAWN BY THE FAMILY LESS THAN 24 HOURS AFTER DELIVERY. THE DATE OF DEATH WAS 9/25/2021 AT 1840." ACCORDING TO THE CUSTOMER THE BABY'S CAUSE OF DEATH ON THE DEATH CERTIFICATE WAS "RESPIRATORY FAILURE RELATED TO SEVER HYPOXIC ISCHEMIC ENCEPHALOPATHY". ON 11/23/2021 A DISCUSSION WITH THE PHYSICIAN PROVIDED THE FOLLOWING ADDITIONAL INFORMATION. THE MOTHER WAS MORBIDLY OBESE WITH A BMI OF 40. HER PRIOR CESAREAN SECTION WAS LOW TRANSVERSE FOR FETAL DISTRESS. SHE REPORTED THAT THE MOM HAD A SPONTANEOUS LABOR WUGMENTED WITH PITOCIN AND AN ARTIFICIAL RUPTURE OF THE MEMBRANES WITH CLEAR FLUID. AN INTRAUTERINE PRESSURE (IUCP) CATHETER WAS PLACED AND NO AMNIO INFUSION WAS PERFORMED. A FETAL SCALP ELECTRODE WAS PLACED AND THERE WAS A FETAL HEAR DECELERATION NOTED BY THE NURSE. THE PHYSICIAN DID NOT HAVE THE INFORMATION TO PROVIDE THE ANSWERS FOR HOW LONG WAS THE DECELERATION AND WHAT WAS THE HEART RATE. AT THE TIME OF DECISION FOR THE CESARIAN SECTION THE FETAL HEART RATE HAD RECOVERED BUT HAD REDUCED VARIABILITY. IT WAS FURTHER REPORTED THAT THE MOTHER PUSHED FOR 2 HOURS - VERTEX, FULLY DILATED BUT THE POSITION OF THE BABY WAS NOT RECALLED. ONCE THE DECISION WAS MADE FOR THE CESAREAN SECTION THERE WAS DIFFICULTY IN DOSING THE EPIDURAL. THE SCALP ELECTRODE AND IUCP WERE REMOVED. SHE STATED THE FETAL PILLOW WAS INSERTED BUT NEVER INFLATED. THE POSTERIOR RUPTURE WAS NOT NOTED UNTIL THE END OF THE PERITONEAL PORTION OF THE PROCEDURE. SHE FURTHER REPORTED DURING THE DISCUSSION THAT IT EXTENDED ON THE RIGHT FROM THE MID-FUNDAL POSITION 8CM TO THE CERVICAL-VAGINAL JUNCTION. SHE STATED ANOTHER PHYSICIAN PERFORMED A CYSTOSCOPY AT THE CONCLUSION OF THE PROCEDURE (URETERS WERE INTACT) AND REMOVED THE INTACT FETAL PILLOW. THE BABIES BLOOD GASES WERE REPORTED AS: ATRIAL CORD GAS: 6.86 BD/BE -23 VENOUS CORD GAS: 7.04 BD/BE -13 H11: CORRECTED DATA B2 - CORRECTED DATE OF BABY'S DEATH TO 9/25/2021 AT THIS TIME COOPERSURGICAL, INC IS CURRENTLY INVESTIGATING THE REPORTED EVENT . ONCE THE ROOT CAUSE INVESTIGATION HAS COMPLETED A FOLLOW UP REPORT WILL BE FILED.
THIS CASE WITH MANUFACTURING REPORTING NUMBER 1216677-2021-00240 IS RELATED TO THE CASE WITH MANUFACTURING REPORTING NUMBER 1216677-2021-00241. REFERENCE REPORT - 1216677-2021-00240 FETAL PILLOW BOX OF 6 FP-010. (B)(4).
THIS CASE WITH MANUFACTURING REPORTING NUMBER 1216677-2021-00240 IS RELATED TO THE CASE WITH MANUFACTURING REPORTING NUMBER. REFERENCE REPORT - (B)(4). FETAL PILLOW BOX OF 6 FP-010 (B)(4).
AT THIS TIME COOPERSURGICAL, INC IS CURRENTLY INVESTIGATING THE REPORTED EVENT . ONCE THE ROOT CAUSE INVESTIGATION HAS COMPLETED A FOLLOW UP REPORT WILL BE FILED.
IT WAS REPORTED THAT THE FETAL PILLOW WAS USED DURING A C-SECTION OF A MOTHER WHO WAS AT 39 WEEKS AND 5 DAYS GESTATION. INFORMATION OF GRAVIDA AND PARA WAS NOT REQUESTED; HOWEVER, WHEN CALLED TO GATHER FURTHER INFORMATION THE HEALTHCARE PROFESSIONAL STATED THAT THE MOTHER HAD A PRIOR C-SECTION. IT WAS REPORTED THAT THE FETAL PILLOW WAS PLACED OVER AN INTACT SCAR PRIOR TO THE MOTHER'S POSTERIOR UTERINE RUPTURE. THE NURSE THAT ANSWERED ADDITIONAL QUESTIONS STATED THE MOTHER WAS FULLY DILATED AND THE FETAL HEAD WAS AT ZERO STATION AT THE TIME THE PILLOW WAS PLACED. SHE STATED SHE BELIEVED THE PILLOW WAS INFLATED TO "100 MM" WHEN THE ADDITIONAL QUESTION WAS ASKED ABOUT HOW MANY CC OF SALINE WAS USED TO INFLATE THE FETAL PILLOW. ADDITIONAL INFORMATION REGARDING HOW THE FETAL PILLOW WAS INFLATED IS BEING REQUESTED. THE IFU STATES: INFLATE THE DEVICE WITH 60 CC SALINE PRIOR TO USE TO CHECK THE INTEGRITY OF THE DEVICE. EMPTY THE DEVICE WITH THE SYRINGE PROVIDED BEFORE INSERTION. IT ALSO LATER STATES: IF THE LEGS ARE NOT PLACED FLAT BEFORE INFLATING, THE DEVICE CAN BE EXPELLED OR COULD MOVE DURING INFLATION AND FAIL TO PRODUCE THE DESIRED ELEVATION. A TOTAL OF 180 CC OF SALINE IS REQUIRED TO PRODUCE THE DESIRED ELEVATION (3 SYRINGES OF FLUID). CLOSE THE TAP AFTER FILLING TO STOP THE FLUID FROM LEAKING. INFLATION VOLUME SHOULD NOT EXCEED 180 CC. THE MOTHER HAD A POSTERIOR UTERINE RUPTURE AND POST-PARTUM HEMORRHAGE, AND THE BABY DIED THE DAY AFTER THE C-SECTION. THERE WAS NO REPORT THAT THE DEVICE MALFUNCTIONED. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE NEONATE'S WEIGHT, SEX, AND ETHNICITY AND RACE. REQUESTED MOTHER'S DATE OF BIRTH, WEIGHT, ETHNICITY, AND RACE. ADDITIONAL QUESTIONS REGARDING THE POSITIONING OF THE MOM AND THE PRESENTATION OF THE NEONATE WHEN THE FETAL PILLOW WAS PLACED HAVE BEEN REQUESTED ALONG WITH QUESTIONS REGARDING HOW THE FETAL PILLOW WAS INFLATED. A QUESTION REGARDING WHAT INTERVENTIONS TOOK PLACE BEFORE, DURING, AND AFTER THE MOTHER'S POSTERIOR UTERINE RUPTURE AND HEMORRHAGE HAS BEEN REQUESTED. ALSO REQUESTED THE OUTCOME FOR THE MOTHER. THE ANSWERS TO THESE QUESTIONS ARE STILL FORTHCOMING ALONG WITH A REQUEST FOR THE DEVICE TO BE RETURNED AND THE LOT NUMBER OF THE DEVICE. THIS CASE WITH MANUFACTURING REPORTING NUMBER IS RELATED TO THE CASE WITH MANUFACTURING REPORTING NUMBER 1216677-2021-000241. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1590163 | FETAL PILLOW, BOX OF 6 | FETAL PILLOW | PWB | COOPERSURGICAL INC. | FP-010 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 0 DA | Male | Death |