BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2120977 · Received June 13, 2011

    Report

    Report Number
    1423500-2011-07496
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 1, 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 FOR A LOW DRAIN VOLUME ALARM WAS NOT CONFIRMED DUE TO UNAVAILABLE SAMPLE. A SAMPLE EVALUATION WAS NOT PERFORMED DUE TO UNAVAILABLE SAMPLE. A BATCH REVIEW WAS NOT PERFORMED DUE TO UNKNOWN LOT NUMBER. A ROOT CAUSE WAS NOT IDENTIFIED DUE TO INSUFFICIENT INFORMATION. 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 RENQ-CAPA-(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(6). 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 HOME PATIENT (HP) CONTACTED GLOBAL TECHNICAL SERVICES REGARDING A LOW DRAIN VOLUME ALARM ON THE HOMECHOICE (HC) UNIT DURING INITIAL DRAIN. DURING TROUBLESHOOTING THE HP STATED THERE WERE AIR BUBBLES IN THE PATIENT LINE THAT WERE NOT MOVING. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED WITH ENDING THERAPY AND STARTING OVER WITH NEW SUPPLIES. THE PATIENT WAS INVOLVED BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. A FOLLOW UP WAS DONE VIA PHONE. THE HP DID NOT HAVE ANY IDEA HOW THE AIR ENTERED THE LINES. THE HP DID NOT NOTICE ANYTHING UNUSUAL WITH THE SUPPLIES AT USE THAT NIGHT. THE HP DISCARDED ALL THE SUPPLIES FROM THE NIGHT AND DID NOT PROVIDE THE LOT NUMBER INFORMATION. THE HP WAS CONTINUING THERAPY WITHOUT ANY OTHER COMPLICATIONS. THE HP HAD ALSO NOTIFIED HIS REGISTERED NURSE (RN) REGARDING THE ALARMS. NO FURTHER INFORMATION WAS PROVIDED. THERE WAS NO INJURY OR MEDICAL INTERVENTION 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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR HOME CHOICE