RESERVOIR BAG MARK IV

Additional Manufacturer Narrative

THIS COMPLAINT HAS BEEN RE-EVALUATED AS PART OF A CORRECTIVE ACTION RELATED TO AN OBSERVATION ON RISK MANAGEMENT IDENTIFIED DURING AN FDA INSPECTION. INVESTIGATION: 3PCS RESERVOIR BAG OF MARK IV WERE RETURNED, PER VISUAL CHECK, ALL THREE BAGS WERE DAMAGED. CUSTOMER REPORTED TWO ISSUES: ISSUE 1: NOT SPECIFY THE NUMBER OF TIMES THE DEVICE CAN BE REUSED. ISSUE 2: RESERVOIR BAG BURN AFTER AUTOCLAVING. REGARDING THE REPORTED ISSUE 1 THAT DO NOT SPECIFY THE NUMBER OF TIMES THE DEVICE CAN BE REUSED: AMBU IFU HAD CLEARLY DEFINED THAT THE PRODUCT CAN BE STILLY FULLY FUNCTIONAL FOLLOWING AUTOCLAVING 30 TIMES. REGARDING THE REPORTED ISSUE 2 THAT THE RESERVOIR BAG BURNS AFTER AUTOCLAVING: THE REPORTED ISSUE HAPPENED DURING CUSTOMER REPROCESSING UNDER THE TEMPERATURE 134 C AND DURATION 4MIN BUT DID NOT KNOW THE NUMBER OF TIMES THAT EACH RESERVOIR HAS UNDERGONE THE SELF-CLEANING PROCESS. THE WASHING AND CLEANING PROCESS ARE CARRIED OUT WITH ENZYMATIC DETERGENT, WITH THE DILUTION INDICATED BY THE MANUFACTURER. COMPARED WITH AMBU IFU REQUIREMENT ABOUT THE REPROCESSING, WE CAN SEE THAT CUSTOMER DID NOT FOLLOW AMBU IFU TO DO REPROCESSING. SUGGEST CUSTOMER TO FOLLOW AMBU IFU REQUIREMENT. WE HAVE VERIFIED THAT THE REPORTED PRODUCT CAN BE FUNCTIONAL AFTER 30 TIMES AUTOCLAVING AT 134C +- 4C ACCORDING TO VERIFICATION TEST REPORT AND 30 TIMES OF CLEANING AT WASHING TEMPERATURE 55 C AND RINSING TEMPERATURE 93 C ACCORDING TO CLEANING TEST REPORT. HOWEVER, AMBU HAD CREATED CA FOR FURTHER IMPROVEMENT FOR REPROCESSING METHOD OF MARK IV, AND IT'S ON ACTIONS STATUS. IN ADDITION, AS PER AMBU IFU, AFTER CLEANING, DISINFECTING AND/OR STERILIZING CAREFULLY INSPECT ALL PARTS FOR DAMAGE AND RESIDUALS OR EXCESSIVE WEAR AND REPLACE IF NECESSARY. BESIDES, WE FIND THAT CUSTOMER DID NOT FOLLOW AMBU IFU TO DO REPROCESSING, CUSTOMER DID THE AUTOCLAVING AT 134C FOR 4 MIN, WHILE AMBU IFU REQUIRED THAT STERILISATION BY GRAVITY STEAM AUTOCLAVE RUNNING A FULL CYCLE AT 134 DEGREES CELSIUS FOR 10MINS AT A STANDARD PRESSURE AND THEN DRY 30 MINTUTES, SUGGEST CUSTOMER TO FOLLOW AMBU IFU IN CASE ANY POTENTIAL FAILURE HAPPENED.

Description of Event or Problem

PRETERM NEWBORN (33 WEEKS) FEMALE, WITH A DIAGNOSIS OF NEONATAL ASPHYXIA SECONDARY TO PREMATURE DETACHMENT OF A NORMAL INSERTED PLACENTA GREATER THAN 50%. THE MARK IV WAS USED FOR POSITIVE PRESSURE VENTILATION DURING ADVANCED CARDIOPULMONARY RESUSCITATION. THE CLIENT INFORMS THAT THE RESERVOIRS WERE AUTOCLAVABLE AT 134 ° C FOR 4 MINUTES. PATIENT OUTOME WAS REQUESTED, HOWEVER INFORMATION WAS NOT OBTAINED. ADDITIONAL INFORMATION RECEIVED: A 20-YEAR-OLD PREGNANT MOTHER, WITH A 33-WEEK PREGNANCY, UNDERWENT SURGERY WITH AN EMERGENCY CESAREAN SECTION SECONDARY TO SEVERE PELVIC PAIN AND SUSTAINED FETAL BRADYCARDIA (80 BEATS PER MINUTE). SHE WAS BORN A NEWBORN WITH SEVERE RESPIRATORY DEPRESSION, FOR WHICH SHE WAS TRANSFERRED TO A RESUSCITATION CRIB. TEAM COMPOSED OF ANESTHETIST, 2 MIDWIVES, 2 PEDIATRICIANS AND TENS BEGIN ADVANCED CARDIOPULMONARY RESUSCITATION (CPR). WHEN VENTILATING AT POSITIVE PRESSURE WITH A NEONATAL MANUAL RESUSCITATION BAG, IT DOES NOT WORK BECAUSE THE RESERVOIR IS DAMAGED (BURNED). AN ATTEMPT IS MADE TO VENTILATE WITH A SECOND NEONATAL RESUSCITATION BAG AVAILABLE IN THE WARD UNIT, WHICH ALSO DOES NOT WORK, FOR THE SAME REASON DESCRIBED ABOVE. THIS FORCES THE TEAM TO VENTILATE THE PATIENT WITH AN ADULT MANUAL RESUSCITATION BAG, USING A NEONATAL MASK. THE DELAY IN THE START OF POSITIVE PRESSURE VENTILATION COULD HAVE CONTRIBUTED TO THE SERIOUS CLINICAL CONDITION OF THE PATIENT, WHO IS HOSPITALIZED IN THE NEONATAL INTENSIVE CARE UNIT (NICU) , WITH A RESERVED PROGNOSIS.