BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2051088 · Received April 12, 2011

    Report

    Report Number
    1423500-2011-04383
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 4, 2011
    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 COMPLAINT WAS FROM A CARE GIVER WHO HAD A LEAK COMING OUT OF PATIENT LINE. THE COMPLAINT WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. ROOT CAUSE WAS NOT DETERMINED. A BATCH REVIEW PERFORMED 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT NUMBER WAS NOT PROVIDED; THEREFORE A BATCH REVIEW CANNOT BE CONDUCTED. THE SAMPLE WAS DISCARDED. 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 AFTER NOTICING FLUID COMING OUT OF THE TOP OF THE PATIENT LINE CONNECTED TO A HOME CHOICE (HC) UNIT DURING PRIME. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED TO THE CG THAT THE CAP ON PATIENT LINE IS VENTED IN ORDER TO LET AIR OUT DURING PRIME AND SOMETIMES SOLUTION MAY OVERFILL. THE TSR ADVISED THE CG THAT IF THE LINE WAS PRIMED AND THERE WAS NO AIR IN LINE, THE CG MAY CLOSE THE CLAMP UNTIL PRIMING WAS COMPLETE. THERE WAS PATIENT INVOLVEMENT, BUT NO MEDICAL INTERVENTION OR INJURY WAS REPORTED. A FOLLOW UP WAS DONE VIA PHONE; THE HOME PATIENT (HP) SAID THAT HE DID NOT HAVE HIS BAGS STACKED ON THE HEATER AND HE HAD THE PATIENT LINE IN THE ORGANIZER DURING PRIME. THE HP SAID HE DID NOT NOTICE ANYTHING USUAL WITH THE SUPPLIES. NO SAMPLES WERE AVAILABLE. THE HP SAID HE COMPLETED THAT THERAPY WITHOUT COMPLICATIONS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME H11A09014

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR HOMECHOICE