BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REMANUFACTURED I-PUMP

    MDR report key: 1160483 · Received September 12, 2008

    Report

    Report Number
    6000001-2008-00523
    Event Type
    Injury
    Date Received
    September 12, 2008
    Date of Event
    August 1, 2008
    Report Date
    August 20, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FRN
    PMA / PMN Number
    K993387
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS SENT TO THE MEDICO TECHNICAL DEPARTMENT AT THE DENMARK HOSPITAL FOR EVALUATION. THE REPORTED PROBLEM WAS NOT DUPLICATED OR CONFIRMED. THE DEVICE HAS BEEN RECEIVED BY THE PRODUCT ANALYSIS LAB FOR EVALUATION. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE. INDICATION FOR USE OF THE I-PUMP IS FOR INFUSIONS OF ANESTHETICS, ANALGESICS, AND SEDATIVES ONLY.

    Description of Event or Problem · 1

    ON 08/20/2008 BAXTER RECEIVED A REPORT OF AN I-PUMP NOT MAINTAINING BATTERY POWER DURING A HOME PATIENT INFUSION OF FLOLAN FROM A DENMARK HOSPITAL. THE PATIENT FELT UNCERTAIN THAT THE CORRECT AMOUNT OF MEDICINE WAS BEING ADMINISTERED RESULTING IN THE PATIENT BEING HOSPITALIZED EIGHT DAYS EARLIER. THIS WAS THE FIRST INCIDENT. AFTER 2-3 HOURS OF USE, THE PUMP ALARMED DUE TO A LOW BATTERY. THE PATIENT WAS DISCHARGED TO HOME FIVE DAYS PRIOR TO ORIGINAL DATE. THE PATIENT RECEIVES CONSTANT TREATMENT WITH FLOLAN. THE TREATMENT IS ADMINISTERED THROUGH TWO I-PUMPS, WHERE ONE OF THEM IS IN USE; THE OTHER IS HELD IN RESERVE IN CASE OF THE FIRST BREAKS. FLOLAN IS A TREATMENT THAT MUST BE GIVING CONSTANTLY AND WITHOUT INTERRUPTION. THE PHYSICIAN INDICATED THAT THE PATIENT'S DATA (RESULTS OF A SIX MINUTE WALK TEST) SHOWED THAT THE PATIENT'S SYMPTOMS WORSENED BY 30% - OXYGENATION IS MEASURED CONTINUOUSLY DURING WALKING. THE PATIENT REPORTEDLY EXPERIENCED WEAKNESS, NAUSEA, LACK OF APPETITE, AND DYSPNEA WITH THE PATIENT'S SYMPTOMS INCREASING OVER A TWO-WEEK PERIOD. IN THE TWO-WEEK PERIOD, THE PATIENT REPORTEDLY HAD MANY ALERTS ON THE I-PUMP. THE PHYSICIAN INDICATED, HE DOUBTS THE MEDICINE WAS BEING ADMINISTERED IN THE WAY IT SHOULD HAVE BEEN. THE PATIENT IS AWAITING A LUNG TRANSPLANT AND WHEN THE PATIENT'S CONDITION WORSENED, IT WAS CRITICAL AND LIFE THREATENING. THIS IS THE FIRST OF TWO INCIDENTS FOR THE SAME PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REMANUFACTURED I-PUMP 80FRN FRN BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R BURINEX 1 MG X 1| VIAGRA 50 MG X 3| MARAVAN| KALEROID 750 MG X 2 G| BOSANTEN 125 MG X 2