BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT AMBULATORY INFUSION-AIM PLUS PUMP

    MDR report key: 645620 · Received November 8, 2005

    Report

    Report Number
    2921482-2005-00614
    Event Type
    Injury
    Date Received
    November 8, 2005
    Date of Event
    October 1, 2005
    Report Date
    October 12, 2005
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT ISBEING SUBMITTED IN RESPONSE TO AN FDA LETTER DATED NOVEMBER 21, 2005. THE CUSTOMER CONTACT STATED THE PATIENT'S DEATH WAS DETERMINED TO BE, "ACCIDENTAL DUE TO A COMBINATION OF PILLS THAT WERE GIVEN." THE DEVICE PASSED TESTING AT THE USER FACILITY AND WILL NOT BE RETURNED TO THE MANUFACTURER FOR FURTHER TESTING.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A DEATH WHILE THE DEVICE WAS IN USE. ON AN UNSPECIFIED DATE AND TIME THE PUMP WAS PROGRAMMED TO DELIVER MORPHINE WITH AN UNSPECIFIED CONCENTRATION. NO PROGRAMMING PARAMETERS WERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME, A NURSE ENTERED THE PT'S ROOM AND NOTED THE PT WAS UNRESPONSIVE. THE PT WAS TREATED WITH OXYGEN THERAPY, MANUALLY VENTILATED AND CARDIOPULMONARY RESUSCITATION WAS PERFORMED. THE CUSTOMER CONTACT REPORTED RESUSCITATION ATTEMPTS WERE UNSUCCESSFUL AND THE PT EXPIRED. THE PUMP WAS REMOVED FROM CLINICAL SERVICE AND SENT TO THE BIOMEDICAL DEPARTMENT. IT WAS REPORTED, DURING TESTING AT THE USER FACILITY, BY A THIRD PARTY BIOMEDICAL COMPANY "THE PUMP CHECKED OUT ACCORDING TO MFR SPECIFICATION AND WORKED APPROPRIATELY." THE CUSTOMER CONTACT STATED, "THE PUMP WAS TESTED BY THE HOSP BIOMED AND A THIRD PARTY AND FOUND NO INDICATION THAT THE PUMP CONTRIBUTED TO THE DEATH." THE AUTOPSY RESULTS WERE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT AMBULATORY INFUSION-AIM PLUS PUMP INFUSION PUMP FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other