BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMBIT PUMP CASSETTE

    MDR report key: 845075 · Received February 28, 2007

    Report

    Report Number
    1722214-2007-00007
    Event Type
    Malfunction
    Date Received
    February 28, 2007
    Report Date
    May 26, 2006
    Manufacturer
    SORENSON MEDICAL, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INITIAL REPORT THAT THE CASSETTE HAD BEEN USED TO INFUSE APPROXIMATELY 2117 ML (2.1 LITERS), IT APPEARS THAT THE SUGGESTED PRACTICE THAT THE CASSETTE SHOULD NOT BE USED FOR MORE THAN 2 LITERS, AS STATED IN THE CLINICIAN MANUAL WAS EXCEEDED. IN 2007, A RETROSPECTIVE AUDIT OF COMPLAINT FILES WAS CONDUCTED FOR COMPLAINTS ASSOCIATED WITH LEAKING CASSETTES, WHERE THE DEVICE WAS BEING USED FOR THE ADMINISTRATION OF CHEMOTHERAPY DRUGS. SINCE THERE IS THE POTENTIAL FOR SERIOUS SIDE EFFECTS FROM THE EXPOSURE OF SOME CHEMOTHERAPY DRUG AGENTS TO UNPROTECTED SKIN, IT WAS THE OPINION OF OUR CLINICAL REVIEW BOARD TO IDENTIFY A CASSETTE LEAKAGE WHERE CHEMOTHERAPY DRUGS WERE INVOLVED AS AN MDR-REPORTABLE INCIDENT.

    Description of Event or Problem · 1

    A DOCTOR REPORTED A LEAKING CASSETTE WITH CHEMOTHERAPY. THE LEAK APPEARED APPROXIMATELY 10 HOURS INTO THE INFUSION ON DAY 3. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENT ASSOCIATED WITH THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMBIT PUMP CASSETTE AMBULATORY INFUSION PUMP CASSETTE FRN SORENSON MEDICAL, INC. NA 511029

    Patients

    Seq Age Sex Outcome Treatment
    1 *