BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPUMP

    MDR report key: 2200964 · Received August 11, 2011

    Report

    Report Number
    6000001-2011-18216
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 17, 2011
    Report Date
    July 22, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K052973
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).THE SAMPLE WAS RETURNED FOR EVALUATION HOWEVER, THE EVALUATION HAS NOT YET BEEN COMPLETED. ONCE THE EVALUATION IS COMPLETE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE CONDITION OF AN IPUMP IN WHICH THE BATTERY DOOR WAS NOT HOLDING IN THE BATTERY WAS CONFIRMED AND REPRODUCED DURING PRODUCT EVALUATION. THE ASSIGNABLE CAUSE WAS NOT IDENTIFIED. DUE TO ESTIMATE REFUSAL BY THE CUSTOMER, NO REPAIRS WERE MADE TO FIX THE REPORTED CONDITION.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED AN IPUMP WITH A CONDITION OF "BATTERY COVER IS NOT HOLDING THE BATTERY IN THE COMPARTMENT PROPERLY CAUSING PUMP TO NOT INFUSE". THIS CONDITION HAS THE POTENTIAL TO INTERRUPT DELIVERY. THE PROCESS STEP IS UNKNOWN. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY ACCORDING TO THE HOSPITAL REPRESENTATIVE. NO PATIENT INVOLVEMENT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IPUMP PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1