BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2250194 · Received September 15, 2011

    Report

    Report Number
    1423500-2011-12274
    Event Type
    Malfunction
    Date Received
    September 15, 2011
    Date of Event
    September 6, 2011
    Report Date
    September 6, 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 IS FOR A REPORT OF A SYSTEM ERROR 2240 ALARM. COMPLAINT IS NOT CONFIRMED AND THE ASSIGNABLE CAUSE IS UNDETERMINED BECAUSE SAMPLE IS UNAVAILABLE. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THIS ISSUE HAS BEEN ESCALATED TO CAPA.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE AND THE LOT NUMBER IS UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    DURING ASSISTANCE WITH A SYSTEM ERROR (SE) 2240 THAT OCCURRED ON THE HOMECHOICE (HC) DURING USE, DURING DWELL 2; THE PATIENT REVEALED THAT THEY HAD CUT OPEN THE BAGS WITH A KNIFE. THE PATIENT STATED THAT THE BAGS APPEARED TO BE DEFECTIVE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP WITH TROUBLESHOOTING AND STARTING OVER WITH NEW SUPPLIES. DURING A FOLLOW-UP WITH THE HOME PATIENT (HP) REGARDING THE REPORTED PROBLEM, THE HP STATED EVERYTHING WENT FINE. THE HP STATED THAT THEY DID NOT START OVER WITH NEW SUPPLIES, THEY JUST USED MANUAL SUPPLIES THE NEXT DAY. THEY DID TALK TO THEIR NURSE REGARDING THE ALARMS AS WELL. THERAPY HAS BEEN CONTINUING AS NORMAL. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR HOMECHOICE