BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVANCE CS2

    MDR report key: 13900738 · Received March 25, 2022

    Report

    Report Number
    2112667-2022-00656
    Event Type
    Injury
    Date Received
    March 25, 2022
    Date of Event
    April 30, 2021
    Report Date
    May 23, 2022
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    K172045
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED. PATIENT IDENTIFIER, ETHNICITY, AND RACE: NOT PROVIDED. SERIAL NUMBER: NOT PROVIDED. REPORT SOURCE OTHER: MEDWATCH REPORT # (B)(4). DATE OF DEVICE MANUFACTURE: UNKNOWN AS NO SERIAL NUMBER PROVIDED. LEGAL MANUFACTURER: HCS (B)(4). DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 0

    THE ROOT CAUSE OF THE PATIENT EXPERIENCING HIGH PEEP (POSITIVE END-EXPIRATORY PRESSURE) WAS DETERMINED BY THE CLINICIAN DURING USE: OVER-PRESSURE RESULTING FROM A CLOSED SCAVENGING VALVE, CREATING A CONDITION IN WHICH PRESSURE COULD NOT BE RELIEVED FROM THE PATIENT CIRCUIT. THERE IS NOT ENOUGH INFORMATION TO DETERMINE WHETHER THE HIGH PEEP CONTRIBUTED TO THE CARDIAC ARREST ONE HOUR AFTER THE PATIENT EXPERIENCED HIGH PEEP.

    Description of Event or Problem · 0

    PER MEDWATCH REPORT # (B)(4): PATIENT IS TODDLER-AGED FEMALE WITH MULTIPLE CONGENITAL CONDITIONS, INCLUDING OEIS COMPLEX (OMPHALOCELE-EXSTROPHY-IMPERFORATE ANUS-SPINAL DEFECTS), WHO PRESENTED FOR PLANNED CLOACAL EXSTROPHY CLOSURE. INTRAOPERATIVELY, PATIENT BECAME HEMODYNAMICALLY UNSTABLE, AND INTERVENTIONS PERFORMED TO STABILIZE PATIENT. DURING TROUBLESHOOTING FOR CAUSE OF HEMODYNAMIC CHANGES, IT WAS DISCOVERED THAT THE VENTILATOR WAS ALARMING FOR HIGH PEEP (POSITIVE END-EXPIRATORY PRESSURE, 8-12 BUT WAS SET TO DELIVER AT 5) AND, AFTER TROUBLESHOOTING THE ANESTHESIA VENTILATOR SCAVENGE SYSTEM, THE SCAVENGER BAG WAS NOTED TO BE FULL/TAUT AND THE VALVE IN A CLOSED POSITION. AFTER FULLY OPENING THE SCAVENGER VALVE, PEEP DECREASED, AND BP (BLOOD PRESSURE) IMPROVED. APPROXIMATELY ONE HOUR LATER, PATIENT SUSTAINED HYPERKALEMIC CARDIAC ARREST AND WAS RESUSCITATED. PERIOD OF INCREASED INTRATHORACIC PRESSURE SECONDARY TO ELEVATED PEEP SUSPECTED TO BE ONE OF CAUSAL FACTORS LEADING TO METABOLIC DERANGEMENTS/HYPERKALEMIA FOR THIS PATIENT. GE HEALTHCARE WILL SUBMIT A FOLLOW-UP REPORT WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1010142 AVANCE CS2 ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Female Required Intervention