BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 14989036 · Received July 12, 2022

    Report

    Report Number
    1416980-2022-03603
    Event Type
    Malfunction
    Date Received
    July 12, 2022
    Date of Event
    June 16, 2022
    Report Date
    August 8, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    MEB
    UDI-DI
    00085412579399
    PMA / PMN Number
    K071222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER ADDRESS: (B)(6). THE DEVICE WAS RECEIVED AND IS CURRENTLY AWAITING EVALUATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    D4: CATALOGUE #: THE CORRECT CATALOGUE # IS ¿2C2009K¿, PREVIOUSLY SUBMITTED AS ¿2C2009KP¿. G4: 510K #: REMOVE ¿K071222¿ AND REPLACED WITH ¿NA¿. H4: THE LOT WAS MANUFACTURED FROM JANUARY 18, 2022 TO JANUARY 19, 2022. THE ACTUAL DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED USING THE NAKED EYE WHICH REVEALED TRACES OF SILICONE OIL LOCATED ON THE INTERIOR WALL OF THE HOUSING. THE MANUFACTURING PROCESS REQUIRES SILICONE OIL TO BE APPLIED BY A VALIDATED AMOUNT TO THE EXTERIOR OF THE ELASTOMERIC BLADDER TO PREVENT POTENTIAL RUPTURE FROM COVER/HOUSING CONTACT. SMALL AMOUNT OF SILICONE OIL FROM THE BLADDER MAY HAVE COME IN CONTACT WITH THE INTERIOR WALL OF THE HOUSING DURING MANUFACTURING; THIS CONDITION IS COSMETIC AND HAS NO IMPACT ON THE FUNCTIONALITY OF THE PRODUCT. THE REPORTED CONDITION WAS IDENTIFIED AS SILICONE OIL; HOWEVER, THE PRODUCT MET SPECIFICATIONS. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A LARGE VOLUME INFUSOR HAD UNKNOWN LIQUID INSIDE THE DEVICE. THIS OCCURRED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1670437 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE CORPORATION NA 22A021 00085412579399

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown