BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1834329 · Received September 14, 2010

    Report

    Report Number
    1423500-2010-03419
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Date of Event
    August 25, 2010
    Report Date
    August 25, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT FOR A SYSTEM ERROR 2240 (AIR IN SET) WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE; THEREFORE, THE ROOT CAUSE COULD NOT BE DETERMINED. A BATCH REVIEW WAS NOT PERFORMED BECAUSE THE LOT NUMBER IS UNKNOWN. THE LABELING REVIEW FOUND THAT THE LABELING WAS ADEQUATE FOR THE POTENTIAL USE ERROR IDENTIFIED IN THIS COMPLAINT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED, THEREFORE, BAXTER CANNOT DETERMINE THE ROOT CAUSE. SINCE THE LOT NUMBER IS NOT AVAILABLE A BATCH REVIEW WILL NOT BE CONDUCTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR LUMBAR INTERBODY FUSION. IT WAS REPORTED THAT DURING INSERTION OF THE BONE SCREW THE TIP OF THE SCREWDRIVER BROKE OFF. A SCREW POST CUTTER WAS USED TO RETRIEVE THE BROKEN PIECES OF THE DRIVER. ALL OF THE PIECES WERE REMOVED FROM THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER AND REPORTED RECEIVING A SYSTEM ERROR 2240 ALARM (AIR IN LINE) ON THE HOMECHOICE (HC) MACHINE DURING DRAIN 1 OF 4. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HOME PATIENT'S (HP) CAREGIVER (CG). THE CG STATES THAT THE HP HAD DISCONNECTED TO USE THE BATHROOM, BUT THEN RECONNECTED BEFORE THE ALARM OCCURRED. THE TSR ADVISED THE CG TO HAVE THE HP DISCONNECT AND START OVER WITH NEW SUPPLIES. PRODUCT SURVEILLANCE CONTACTED THE NURSE ON (B)(6) 2010 REGARDING THE PATIENT DISCONNECTING AND RECONNECTING. ACCORDING TO THE NURSE THE PATIENT HAS RESUMED SUCCESSFULLY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

    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 59 YR