BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 12492728 · Received September 17, 2021

    Report

    Report Number
    1416980-2021-05806
    Event Type
    Malfunction
    Date Received
    September 17, 2021
    Date of Event
    August 26, 2021
    Report Date
    October 21, 2021
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    MEB
    PMA / PMN Number
    K011317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO D4: CATALOGUE #: THE CORRECT CATALOGUE # IS ¿2C9961KP¿, PREVIOUSLY SUBMITTED AS ¿IN2C9961KP.¿ D4: UNIQUE IDENTIFIER (UDI) #: THE UDI # IS (01)00085412081502, PREVIOUSLY SUBMITTED AS ¿NI.¿ G4: THE 510K # IS ¿K011317¿, PREVIOUSLY SUBMITTED AS ¿NA¿. THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, A PHOTOGRAPH OF THE SAMPLE WAS PROVIDED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED ON THE PHOTOGRAPH WHICH SHOWED AN IMAGE OF MULTIRATE CONTROL MODULE AND DID NOT SHOW EVIDENCE OF LEAK. 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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DROP OF DRUG WOULD LEAK FROM THE DIAL OF AN INDIA CE MULTIRATE INFUSOR APPROXIMATELY EVERY 30 MINUTES. THE LEAK WAS OBSERVED DURING AN UNSPECIFIED PATIENT INFUSION. THERE WAS NO 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
    1386196 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE CORPORATION NA 21D029

    Patients

    Seq Age Sex Outcome Treatment
    1 UNSPECIFIED DRUG