BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6000096-1999-00082

    MDR report key: 257455 · Received December 30, 1999

    Report

    Report Number
    6000096-1999-00082
    Event Type
    Malfunction
    Date Received
    December 30, 1999
    Date of Event
    December 3, 1999
    Report Date
    December 6, 1999
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    RECEIVED REPORT OF DELAY IN TREATMENT. THE PT WAS RECEIVING HOME CARE TREATMENT OF TPN INFUSION WITH ORDER FOR 1000CC OVER A TEN HOUR PERIOD WITH ONE HOUR TAPER UP AND TAPER DOWN. THE INFUSION WAS BEGUN BY A HOME HEALTH NURSE ON 12/02/1999 AT APPROX. 7PM VIA A SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL CATHETER LINE USING AN "AIM" PLUS INFUSION PUMP. THE PT CALLED THE HOME CARE OFFICE AT APPROX. 5AM TO REPORT PUMP ALARMING OCCLUSION ALTERNATELY WITH CHECK CARTRIDGE ALARM. WHEN TROUBLESHOOTING BY THE NURSE OVER THE TELEPHONE WAS NOT SUCCESSFUL, A HOME VISIT WAS MADE. THE NURSE CHANGED THE TUBING WITH A DIFFERENT LOT# AND THE INFUSION CONTINUED WITHOUT FURTHER INCIDENT. THE PUMP DISPLAY INDICATED 1.1CC INFUSED WHICH MATCHED THE AMOUNT GONE FROM THE BAG. IT WAS NOTED THAT THE PUMP DID NOT ALARM UNTIL 7.5 HOURS AFTER THE INFUSION WAS BEGUN DESPITE NON-DELIVERY OF THE TPN. THERE WAS NO REPORT OF PT HARM AND THE TPN SCHEDULE WAS ABLE TO RESUME WITH MODIFICATION OF THE NEXT START TIME. NO ADD'L INFO WAS AVAILABLE.

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other ABBOTT AIM PLUS INFUSION DEVICE.