BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2070062 · Received April 26, 2011

    Report

    Report Number
    1423500-2011-05066
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 8, 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 CONNECTION ISSUE WAS NOT CONFIRMED DUE TO UNAVAILABLE SAMPLE. THE SAMPLE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, THE ROOT CAUSE COULD NOT BE DETERMINED. A BATCH REVIEW WAS NOT PERFORMED DUE TO UNKNOWN LOT NUMBER. RENAL QUALITY ENGINEERING, ALONG WITH PLANT QUALITY AND MANUFACTURING PERSONNEL, WILL CONTINUE TO MONITOR THIS PRODUCT LINE FOR TRENDS AND WILL TAKE CORRECTIVE/PREVENTIVE ACTION AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED AND THE LOT NUMBER IS UNKNOWN. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    THE CALLER CONTACTED BAXTER'S (B)(4) TO END THERAPY, WHICH OCCURRED ON THE HOMECHOICE (HC), DURING USE DURING DWELL 2. THE HOME PATIENT (HP) STATED THAT THE SUPPLY BAG BECAME DISCONNECTED. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP WITH ENDING THERAPY. THE HP WANTED TO COMPLETE THERAPY USING MANUAL SUPPLIES. THE HC WAS OPERATIONAL. THE SOLUTION TO THIS ISSUE WAS PROVIDED OVER THE PHONE AND A SWAP OF THE DEVICE WAS NOT NECESSARY. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. THE HOME PATIENT (HP) WAS CONTACTED ON (B)(6) 2011. THE HP STATED THAT THE BAG FELL OFF THE TABLE AND DISCONNECTED BUT DID NOT KNOW WHY IT FELL. THE HP HAD ALREADY DISCARDED BOTH THE BAG AND CASSETTE AND DID NOT KNOW THE LOT NUMBERS OF THE BAG OR CASSETTE. THE HP STATED THEY COMPLETED THEIR THERAPY WITH MANUAL SUPPLIES AND THEIR THERAPY HAD BEEN GOING WELL.

    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 64 YR HOMECHOICE