BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1914786 · Received December 4, 2010

    Report

    Report Number
    1423500-2010-06522
    Event Type
    Malfunction
    Date Received
    December 4, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 8, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS FOR A REPORT OF A CHECK SUPPLY LINE. THE USED SAMPLE WAS NOT RETURNED TO BAXTER FOR EVALUATION. PER THE REPORT, THE PATIENT NOTICED THAT THE SUPPLY BAG WAS NOT COMPLETELY SPIKED. FROM THE DATA WITHIN THE REPORT, THE ROOT CAUSE WAS USER ERROR. THIS REVIEW FOUND THE LABELING ADEQUATE FOR THE USER ERROR IN THE COMPLAINT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT NUMBER WAS NOT PROVIDED; THEREFORE A BATCH REVIEW CANNOT BE CONDUCTED. THE SAMPLE IS NOT AVAILABLE AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Description of Event or Problem · 1

    A CARE GIVER (CG) CONTACTED GLOBAL TECHNICAL SERVICES REGARDING A CHECK SUPPLY LINE ALARM THAT OCCURRED ON THE HOME CHOICE (HC) UNIT DURING PRIME. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE CG CHECK THE SUPPLY LINE FOR KINKS/CLOSED CLAMPS; THE CG FOUND THE SPIKE WAS NOT PUSHED IN ALL THE WAY. THE CG PUSHED IN THE SPIKE THIS CORRECTED THE ALARM AND THE PRIME RESUMED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR