BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 12354033 · Received August 23, 2021

    Report

    Report Number
    1416980-2021-05161
    Event Type
    Malfunction
    Date Received
    August 23, 2021
    Date of Event
    July 28, 2021
    Report Date
    September 22, 2021
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    MEB
    UDI-DI
    00085412579412
    PMA / PMN Number
    K041738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION MADE TO G4: PMA/510K #: K041738 (PREVIOUSLY SUBMITTED AS NA) ADDITIONAL INFORMATION WAS ADDED TO H3, H4, H6 AND H10. H10: THE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED FLUID INSIDE THE BAG THAT CONTAINED THE SAMPLE WHICH SUGGESTED A LEAK MAY HAVE OCCURRED. THE CAUSE OF THE FLUID INSIDE THE BAG WAS DUE TO THE BROKEN TUBING (DETACHED) AT THE JUNCTION OF THE WHITE FLOW RESTRICTOR. FURTHER INSPECTION REVEALED THAT THE PORTION OF THE BROKEN TUBING REMAINED INSIDE THE SOLVENT-BONDED AREA OF THE FLOW RESTRICTOR. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE LEAK WAS DUE TO THE BROKEN TUBING, HOWEVER THE CAUSE OF THE BROKEN TUBING COULD NOT BE DETERMINED. 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

    (B)(6). 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 AN INFUSOR LV (LARGE VOLUME) LEAKED FROM AN UNKNOWN LOCATION. THE DEVICE WAS FILLED WITH CEFTRIAXONE 4000MG IN SODIUM CHLORIDE 0.9%. THE ISSUE WAS IDENTIFIED AT THE HOSPITAL BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1250004 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE CORPORATION NA 21D011 00085412579412

    Patients

    Seq Age Sex Outcome Treatment
    1