BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 10236052 · Received July 6, 2020

    Report

    Report Number
    1416980-2020-03786
    Event Type
    Malfunction
    Date Received
    July 6, 2020
    Date of Event
    June 8, 2020
    Report Date
    August 3, 2020
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    MEB
    UDI-DI
    00085412081359
    PMA / PMN Number
    K071222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION MADE TO G5: PMA/510K #: K071222 (PREVIOUSLY NA). ADDITIONAL INFORMATION WAS ADDED TO H3, H4 AND H6. H4: THE DEVICE WAS MANUFACTURED FROM AUGUST 26, 2019 - AUGUST 28, 2019. H10: THREE (3) ACTUAL DEVICES WERE RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED USING THE NAKED EYE NOTED THE YELLOW COIL CAP HAD SEPARATED FROM THE HOUSING. THE DIRECT CAUSE OF THE SEPARATED COIL CAP CONDITION WAS DUE TO MALFORMED HOUSING. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE MALFORMED HOUSING WAS DUE TO EXTREME HEAT TEMPERATURE DURING SHIPPING. A NONCONFORMANCE HAS BEEN OPENED TO ADDRESS THIS ISSUE. 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.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS IN PROGRESS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COIL CAP OF 3 LARGE VOLUME INFUSORS SEPARATED FROM THE HOUSING. THESE EVENTS WERE OBSERVED 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
    699083 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE CORPORATION NA 19H021 00085412081359

    Patients

    Seq Age Sex Outcome Treatment
    1