BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2110593 · Received June 1, 2011

    Report

    Report Number
    1423500-2011-06924
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 16, 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). DURING INVESTIGATION BY BAXTER, THIS INCIDENT WAS DETERMINED TO BE CAUSED BY USE/USER ERROR AND THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION. THEREFORE A BATCH REVIEW AND SAMPLE EVALUATION WILL NOT BE CONDUCTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR THE SYSTEM ERROR 2240 (AIR IN LINE) OCCURRED DURING DWELL 3 OF 5 WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED GLOBAL TECHNICAL SERVICES REGARDING A SYSTEM ERROR (SE) 2240 ALARM THAT OCCURRED ON THE HOME CHOICE (HC) UNIT DURING DWELL. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP WITH CLEARING THE ALARM THEN EXPLAINED A SE 2240 INDICATES A LARGE AMOUNT OF AIR HAS ENTERED SETUP AND THAT THE HP NEEDED TO END THERAPY AND CONTACT THEIR NURSE. THERE WAS PATIENT INVOLVEMENT. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED. A FOLLOW UP WAS DONE VIA PHONE CALL. THE HP STATED HE ACCIDENTALLY PULLED OFF THE CAP ON AN UNUSED SUPPLY LINE CAUSING AIR TO ENTER THE SET. THE HP CONFIRMED HE WAS CONNECTED WHEN THIS OCCURRED. THE HP EXPLAINED THAT HE DISCARDED THE SAMPLE AND DID NOT KNOW THE LOT NUMBER. THE HP STATED HE NOTIFIED HIS NURSE OF THE ALARM WHO ADVISED HIM ON PROPER PROCEDURES. THE HP ADVISED THAT HE WAS ABLE TO RESUME THERAPY SUCCESSFULLY WITH NEW SUPPLIES. PER THE HP, HE WAS DOING WELL ON THERAPY. THERE WAS NO PATIENT 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 60 YR HOME CHOICE