BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 10276759 · Received July 15, 2020

    Report

    Report Number
    1416980-2020-04015
    Event Type
    Malfunction
    Date Received
    July 15, 2020
    Date of Event
    June 18, 2020
    Report Date
    August 13, 2020
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    MEB
    UDI-DI
    00085412081366
    PMA / PMN Number
    K071222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION MADE TO G5: PMA/510K #: K071222 (PREVIOUSLY NA) ADDITIONAL INFORMATION WAS ADDED TO H4 AND H6. H4: THE LOT WAS MANUFACTURED BETWEEN OCTOBER 22, 2019 TO OCTOBER 23, 2019. H10: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED A LARGE VOLUME INFUSOR UNDER INFUSED MEDICATION TO A PATIENT VIA PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) LINE. THE EXPECTED DELIVERY TIME WAS 24 HOURS; HOWEVER, AFTER THE EXPECTED DELIVERY TIME WAS COMPLETED, IT WAS OBSERVED THAT APPROXIMATELY A QUARTER DOSE WAS STILL LEFT IN THE DEVICE AND HAD NOT BEEN DELIVERED TO THE PATIENT. THE DEVICE HAD BEEN FILLED WITH 3G OF VANCOMYCIN RECONSTITUTED WITH 5ML OF WATER FOR A TOTAL VOLUME OF 40ML. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739991 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE CORPORATION NA 19K049 00085412081366

    Patients

    Seq Age Sex Outcome Treatment
    1 PICC LINE| VANCOMYCIN| WATER DILUTION| PICC LINE| VANCOMYCIN| WATER DILUTION