BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 10385646 · Received August 10, 2020

    Report

    Report Number
    1416980-2020-04844
    Event Type
    Malfunction
    Date Received
    August 10, 2020
    Date of Event
    July 15, 2020
    Report Date
    September 10, 2020
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    MEB
    UDI-DI
    00085412081663
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS ADDED TO D10, H3, H4 AND H6. H4: DEVICE MANUFACTURED BETWEEN JUNE 8, 2018 TO JUNE 9, 2018. H10: THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. AFTER THE LUER CAP WAS REMOVED, EVIDENCE OF CONTINUOUS FLOW WAS OBSERVED AT THE DISTAL LUER. FUNCTIONAL TESTING WAS PERFORMED WITH NO ISSUES NOTED. THE REPORTED CONDITION WAS NOT VERIFIED. 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

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HALF-DAY INFUSOR DID NOT INFUSE DURING PATIENT USE. THE DEVICE HAD BEEN FILLED WITH 480MG DESFERRIOXAMINE IN 50ML 0.9% SODIUM CHLORIDE. IT WAS FURTHER REPORTED THAT A NON-BAXTER NEEDLE WAS USED TO RESTART THE INFUSION IN THE OTHER LEG, HOWEVER THE DEVICE DID NOT INFUSE. FLOW WAS DETECTED PRIOR TO CONNECTION. 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
    850863 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE CORPORATION NA 18F011 00085412081663

    Patients

    Seq Age Sex Outcome Treatment
    1 29G THALASET NEEDLE| DESFERRIOXAMINE| SODIUM CHLORIDE| 29G THALASET NEEDLE| DESFERRIOXAMINE| SODIUM CHLORIDE