BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3 PRONG

    MDR report key: 1894446 · Received November 9, 2010

    Report

    Report Number
    1423500-2010-05539
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    October 11, 2010
    Report Date
    October 11, 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). AN ENGINEERING QUALITY REVIEW WAS COMPLETED FOR THIS REPORT OF A SYSTEM ERROR 2240. THE REPORT WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. BASED ON THE INFORMATION OBTAINED FROM BAXTER?S INVESTIGATION, THE ROOT CAUSE OF THE SE 2240 WAS NOT DETERMINED. THE BATCH REVIEW WAS PERFORMED ON THE POTENTIALLY ASSOCIATED LOT NUMBER WITH NO ISSUES NOTED. 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). A BATCH REVIEW WILL BE PERFORMED FOR THE LOT NUMBER PROVIDED. THE SAMPLE WAS DISCARDED. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION RESULTING IN FIXTURE LOSS. NO ADDITIONAL DETAILS ARE AVAILABLE AS OF THE DATE OF THIS REPORT. REIMPLANTATION IS PLANNED BUT HAS NOT TAKEN PLACE AT THE TIME OF THIS REPORT (B)(4), 2010.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED GLOBAL TECHNICAL SERVICES TO REPORT A SYSTEM ERROR (SE) 2240 ALARM THAT OCCURRED ON THE HOMECHOICE (HC) UNIT DURING DWELL 4 OF 5. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HP TO CYCLE POWER TO END THE THERAPY. THE TSR EXPLAINED SE 2240 INDICATES A LARGE AMOUNT OF AIR HAS ENTERED SETUP. THE HP CONFIRMED THERAPY ENDED AND SHE WOULD CONTACT HER NURSE TO INFORM OF THE INCIDENT. THE TSR REVIEWED PROPER PROCEDURES PER THE USER MANUAL WITH THE HP. THE HP CONFIRMED SHE WOULD CONTINUE THERAPY WITH NEW SUPPLIES. ON (B)(6) 2010 PRODUCT SURVEILLANCE SPOKE WITH THE HOME PATIENT (HP) WHO STATED SHE SETS UP WITH 3 SUPPLY BAGS AND WHEN SHE IS IN DWELL 4, 2 OF THE BAGS ARE EMPTY. THE HP REPORTED NO ADVERSE EVENT AND CONFIRMED SHE NOTIFIED HER NURSE. THE HP STATED THERE HAVE BEEN NO FURTHER ALARMS SINCE THE (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME H10G26131

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR