BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2233778 · Received September 3, 2011

    Report

    Report Number
    1423500-2011-11670
    Event Type
    Malfunction
    Date Received
    September 3, 2011
    Date of Event
    August 16, 2011
    Report Date
    August 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). THIS COMPLAINT FOR A SYSTEM ERROR (SE) 2240 (AIR IN SET) IS CONFIRMED BECAUSE THE PATIENT REPORTED HAVING A CLAMP OPEN ON AN UNUSED SUPPLY LINE DURING THERAPY, WHICH IS USE ERROR THAT CAN CAUSE SYSTEM ERROR 2240 ALARMS. THE LOT NUMBER IS UNKNOWN; THEREFORE A BATCH REVIEW CANNOT BE PERFORMED. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE ADEQUATE FOR THE USE ERROR(S) IN THE COMPLAINT. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR (SE) 2240 (AIR IN LINE) ALARM THAT APPEARED ON THE HOMECHOICE (HC) DISPLAY DURING DRAIN 2. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HOME PATIENT (HP) CYCLE POWER FOR THE HC. THE HP STATED THAT AN UNUSED LINE CLAMP WAS OPEN. THE TSR EXPLAINED THE ALARM AND HAD THE HP CYCLE POWER AGAIN. THE HP WOULD RESTART WITH NEW SUPPLIES AND NOTIFY THE PERITONEAL DIALYSIS NURSE OF THE ALARMS. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL REPORT. PRODUCT SURVEILLANCE CONTACTED THE HP ON (B)(4) 2011 REGARDING THE REPORTED SYSTEM ERROR. THE HP STATED THAT SHE DID HAVE A CLAMP LEFT OPEN ON AN UNUSED SUPPLY LINE. THE HP STATED SHE WAS INSTRUCTED TO START OVER WITH NEW SUPPLIES, WHICH SHE DID. THE HP DID NOT NOTIFY HER NURSE SO SHE WAS ADVISED AGAIN, THAT SHE REALLY SHOULD LET HER NURSE KNOW AND THE HP STATED OK. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT.

    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 75 YR HOMECHOICE