BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT AIM AMBULATORY INFUSION MANAGER

    MDR report key: 132076 · Received November 7, 1997

    Report

    Report Number
    2024064-1997-00060
    Event Type
    Malfunction
    Date Received
    November 7, 1997
    Date of Event
    October 2, 1997
    Report Date
    October 3, 1997
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    FRN
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RECEIVED AND TESTED BY TECHNICAL ENGINEERING STAFF. THE PUMP POWERED ON WITH AN ERROR 16. A REVIEW OF THE PUMP'S HISTORY INDICATED AN ERROR 16 HAD OCCURRED HOWEVER, NO ERROR 100 OR POWER LOSS ALARMS WERE NOTED. THE ERROR 16 MAY INDICATE A LOW LITHIUM BATTERY SO WE MEASURED THE LITHIUM BATTERY AND IT WAS OUT OF SPECIFICATIONS AT 1.81 VOLTS. AFTER THE LITHIUM BATTERY WAS REPLACED, WE RAN A VOLUME ACCURACY TEST USING THE CUSTOMER'S PROTOCOL. THE DOSE WAS 64ML TO BE INFUSED OVE 30 MINUTES AND REPEATED EVERY 6 HOURS, KVO 0.1ML/DL FOR 1 HOUR, AND A CONTAINER SIZE OF 258.3ML. THE EXPECTED AMOUNT WAS 254.54ML AND THE MEASURED AMOUNT WAS 246.54ML. THE PERCENT OF ERROR WAS -301%. THE PUMP INFUSED WITHIN SYSTEM ACCURACY SPECIFICATIONS. THE HISTORY EVENT LOG DOES NOT GO BACK AS FAR AS 10/2/1997, THE REPORTED EVENT DATE. CO FOUND NO INTERMITTENT POWER SOURCES WITH THE EXTERNAL POWER JACK OF BATTERY CONTACTS.

    Description of Event or Problem · 1

    NON-DELIVERY OVER 24 HOURS REPORTED. THE PUMP WAS SET TO INFUSE TIMENTIN IN THE INTERMITTENT MODE, 64ML OVER 30 MINUTES, EVERY 6 HOURS FOR 4 DOSES WITH A 0.1ML/HR KEEP OPEN RATE BETWEEN DOSES. THE PUMP HAD BEEN IN USE WITH THIS PROGRAM SINCE 09/25/1997. ON 10/2/1997 THE PUMP WAS SET WITH THE SAME PROGRAM TO BEGIN AT 15:11. WHEN THE HOMECARE NURSE ARRIVED AT THE PATIENT'S HOME THE FOLLOWING DAY, SHE NOTED THAT NOTHING HAD DELIVERED. THE PUMP HISTORY WAS INCOMPLETE, BUT IT HAD RECORDED A "STUCK KEY ALARM" AND A "POWER LOSS ALARM". THE PATIENT REPORTED THAT HE DID NOT HEAR ANY ALARMS SOUND IN THE PREVIOUS 24 HOUR PERIOD. LAB WORK WAS PERFORMED AND THE PATIENT'S SEDIMENTATION RATE WAS WITHIN NORMAL LIMITS. INTRAVENOUS ANTIBIOTIC THERAPY WAS DISCONTINUED AND THE PATIENT WAS PLACED ON ORAL ANTIBIOTICS. NO ADVERSE EFFECTS WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT AIM AMBULATORY INFUSION MANAGER INFUSION PUMP FRN ABBOTT LABORATORIES NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other