BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROJET PUMP CASSETTE

    MDR report key: 845143 · Received February 28, 2007

    Report

    Report Number
    1722214-2007-00003
    Event Type
    Malfunction
    Date Received
    February 28, 2007
    Date of Event
    December 14, 2005
    Report Date
    January 25, 2006
    Manufacturer
    SORENSON MEDICAL, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBSEQUENCE INFORMATION RECEIVED DETERMINED THE DRUG IN USE WAS 5FU. 5FU DOES NOT REQUIRE MEDICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OF A BODY STRUCTURE. HOWEVER, IF THIS EVENT WAS TO OCCUR WITH OTHER CHEMOTHERAPY DRUGS MEDICAL INTERVENTION MAYBE REQUIRED TO PREVENT PERMANENT IMPAIRMENT. SORENSON MEDICAL HAS DISCONTINUED DISTRIBUTION OF THE MICROJECT PRODUCTS IN 2005. 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 DISTRIBUTOR REPORTED CHEMO LEAKED ON THE PATIENT AND THE NURSE. 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 MICROJET PUMP CASSETTE AMBULATORY INFUSION PUMP CASSETTE FRN SORENSON MEDICAL, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 *