BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2181930 · Received July 28, 2011

    Report

    Report Number
    1423500-2011-09880
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 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). SAMPLE IS AVAILABLE FOR EVALUATION. AN EVALUATION WILL BE PERFORMED ON THE PROVIDED LOT NUMBER. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR (SE) 2240 (AIR IN SET) WAS NOT CONFIRMED DURING SAMPLE EVALUATION. THE ASSIGNABLE CAUSE WAS UNDETERMINED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. 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.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER TECHNICAL SERVICES(BTS) REGARDING ASSISTANCE WITH A SYSTEM ERROR 2240 ALARM DURING DWELL 3 OF 7 ON THE HOMECHOICE MACHINE(HC). THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE CAREGIVER(CG) TO CYCLE POWER. THE TSR ASSISTED THE CG TO CYCLE POWER TO GET TO PRESS GO TO START. THE HP STATED THEY WOULD PERFORM A MANUAL EXCHANGE. THE HOME PATIENT(HP) WAS CONTACTED ON (B)(6) 2011. THE HP STATED HE WAS NOT SURE WHAT MIGHT HAVE CAUSED THE ALARM. THE HP STATED THAT AFTER STARTING OVER WITH NEW SUPPLIES NO FURTHER ISSUES WERE FOUND. THE HP STATED THIS WAS AN ISOLATED INCIDENT. THE HP STATED HE DID NOT DEVELOP ANY ADVERSE REACTIONS OR NEED ANY MEDICAL INTERVENTION. THERE WAS PATIENT INVOLVEMENT; HOWEVER, 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 H11D04084

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR HOMECHOICE PRO