BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE

    MDR report key: 2243456 · Received September 12, 2011

    Report

    Report Number
    1423500-2011-12076
    Event Type
    Malfunction
    Date Received
    September 12, 2011
    Date of Event
    August 29, 2011
    Report Date
    August 29, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K012988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) WAS NOT CONFIRMED DUE TO LACK OF SAMPLE. THE CAUSE WAS UNDETERMINED. RENAL QUALITY ENGINEERING, ALONG WITH PLANT QUALITY AND MANUFACTURING PERSONNEL, WILL CONTINUE TO MONITOR THIS PRODUCT LINE FOR ADVERSE TRENDS AND WILL TAKE CORRECTIVE/PREVENTIVE ACTION AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED. THE LOT NUMBER IS UNKNOWN AT THIS TIME; THEREFORE A BATCH REVIEW WILL NOT BE CONDUCTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REPORTING A SYSTEM ERROR (SE) 2240 (AIR IN SET) DURING DWELL 10 OF 10 ON THE HOME CHOICE (HC). THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE CAREGIVER (CG) TO CLEAR THE ALARM AND INFORMED THE CG OF THE ERRORS MEANING. THE CG STATED THAT THERE WAS SOMETHING WET UNDER THE SUPPLY BAG AND THE BAG WAS HANGING. THE CG WOULD CONTACT THE HOME PATIENT (HP)'S MOTHER AT WORK AND INFORM HER OF THE SYSTEM ERROR. THE MOTHER MAY CALL BAXTER BACK FOR MORE INFORMATION. PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT (HP)'S MOM ON (B)(6) 2011 REGARDING THE SYSTEM ERROR 2240 ALARM. PER THE HP'S MOM, SHE DID NOT NOTICE ANYTHING WITH THE SETUP AS SHE STATED SHE TOOK THE SUPPLIES DOWN AND SHE DID NOT SEE ANY LEAKS IN THE SOLUTION BAGS. THE HP'S MOM STATED THEY DID NOT SET UP WITH NEW SUPPLIES AS THE HP WAS AT THE END OF THERAPY. THE HP'S MOM STATED SHE DID FOLLOW UP WITH THE PERITONEAL DIALYSIS NURSE (PDRN) REGARDING THE ALARM. THE HP'S MOM STATED THE HP RESUMED THERAPY ON THE CYCLER WITHOUT PROBLEMS. THERE WAS PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 35 MO HOMECHOICE