BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOWNSTREAM® CARTRIDGE

    MDR report key: 13972343 · Received April 1, 2022

    Report

    Report Number
    2030964-2022-00005
    Event Type
    Malfunction
    Date Received
    April 1, 2022
    Date of Event
    March 6, 2022
    Report Date
    March 31, 2022
    Manufacturer
    THEROX INC
    Product Code
    MWG
    UDI-DI
    00862478000421
    PMA / PMN Number
    P170027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DOWNSTREAM SSO2 CARTRIDGE INVOLVED IN THE REPORTED COMPLAINT WILL NOT BE RETURNED FOR INVESTIGATION BECAUSE THE CUSTOMER HAS DISPOSED OF IT. THE ROOT CAUSE OF THE REPORTED COMPLAINT BASED ON THE ADDITIONAL INFORMATION FROM THE CUSTOMER SITE WAS USER ERROR DURING THE INSERTION OF DRAW TUBING INTO THE BLOOD PUMP. THE USER IMPROPERLY PLACED THE DRAW TUBING OF THE DOWNSTREAM SSO2 CARTRIDGE OUTSIDE THE BLOOD PUMP "V SLOTS," WHICH RESULTED IN TUBING PUNCTURE RENDERING THE SSO2 CARTRIDGE INOPERABLE. DESPITE ALL THAT, TREATMENT WAS DELIVERED AFTER REPLACING THE CARTRIDGE, AND THE PATIENT RECEIVED SSO2 THERAPY. THE REPORTED EVENT HAS BEEN REVIEWED WITH THE CUSTOMER FOR TRAINING. PER THEROX DOWNSTREAM SYSTEM OPERATORS MANUAL, INSERT THE DRAW LINE INTO THE BLOOD PUMP, ALIGNING IT WITH THE TUBING GUIDES (V SLOTS). AFTER ACHIEVING PROPER ALIGNMENT OF THE DRAW LINE, ROTATE THE BLOOD PUMP LEVER DOWNWARD TO CLOSE THE BLOOD PUMP. THE EVENT WAS ASSESSED AS NOT SERIOUS BECAUSE THE PATIENT DID NOT EXPERIENCE ANY CLINICAL SYMPTOMS RELATED TO BLOOD LOSS. THE EVENT OF BLOOD LOSS WAS CAUSAL RELATED TO THE ZOLL DEVICE AND PROCEDURE BECAUSE IT OCCURRED DUE TO USER ERROR. USER ERROR OCCURRED WHEN DRAW LINE TUBING WAS PLACED INTO THE BLOOD PUMP RESULTING IN PUNCTURE OF TUBING. TROUBLESHOOTING AND EDUCATION PROVIDED TO STAFF REGARDING PROPER PLACEMENT AND LOADING OF DRAW LINE TUBING. THE EVENT IS NOT SERIOUS. THE EVENT OF BLOOD LOSS WAS CAUSAL RELATED TO THE ZOLL DEVICE AND PROCEDURE.

    Description of Event or Problem · 0

    DURING THE SET-UP FOR INITIATING AN SSO2 THERAPY, THE DOWNSTREAM SSO2 CARTRIDGE WAS PRIMED WHEN THE USER NOTICED BLOOD LEAKING FROM DRAW TUBING AT THE BLOOD PUMP. THE USER IMMEDIATELY SHUTDOWN THE THEROX DOWNSTREAM CONSOLE, REMOVED, DISCARDED, AND REPLACED IT WITH A NEW CARTRIDGE. FOLLOWING THIS, THE SSO2 THERAPY WAS SUCCESSFULLY COMPLETED. THE USER IMPROPERLY PLACED THE DRAW TUBING OF THE DOWNSTREAM SSO2 CARTRIDGE OUTSIDE THE BLOOD PUMP "V SLOTS," WHICH RESULTED IN TUBING PUNCTURE RENDERING THE SSO2 CARTRIDGE INOPERABLE. THE USER STATED AN UNKNOWN AMOUNT OF BLOOD LOSS FROM THE DRAW TUBING; HOWEVER, THE PATIENT DID VERY WELL AND WAS DISCHARGED WITH NO COMPLICATIONS REPORTED. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2794249 DOWNSTREAM® CARTRIDGE SYSTEM, OXYGEN, AQUEOUS MWG THEROX INC DSC-2(US DS-1) 00862478000421

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown