BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2160241 · Received July 13, 2011

    Report

    Report Number
    1423500-2011-08991
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 19, 2011
    Report Date
    June 19, 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). ONE SET WAS RECEIVED IN REFERENCE TO SYSTEM ERROR (SE) 2240 ALARM. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. THE SET WAS VISUALLY INSPECTED WITH SOLUTION NOTED THROUGHOUT SET. THE SET WAS PLACED ON HOMECHOICE MACHINE FOR PRIMING AND IT RAN WITH NO ALARMS. NO MANUFACTURING ABNORMALITIES WERE NOTED DURING VISUAL INSPECTION. THE COMPLAINT COULD NOT BE CONFIRMED IN THE LAB. A ROOT CAUSE WAS NOT IDENTIFIED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH RENQ-CAPA-(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE HAS BEEN REPORTED TO BE AVAILABLE FOR EVALUATION AND HAS BEEN REQUESTED. 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 2240 (AIR IN LINE) ALARM THAT APPEARED ON THE HOMECHOICE (HC) DISPLAY DURING DWELL 3 OF 4. THE HOME PATIENT (HP) WAS CONNECTED PRIOR TO PRIMING. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM, ASSISTED TO CLEAR THE ALARM AND ADVISED TO START OVER WITH NEW SUPPLIES OR DO MANUAL EXCHANGE. THE HP WOULD DO MANUAL EXCHANGED. THERE WAS PATIENT INVOLVEMENT BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. DURING A FOLLOW UP WITH THE HP REGARDING THE ALARM, IT WAS REVEALED THAT THE HP HAD NO IDEA HOW THE AIR ENTERED THE LINES. THE HP STATED THAT SHE HAS BEEN DOING THIS THERAPY FOR A LONG TIME AND SHE DID THINGS VERY PRECISELY AND PROPERLY. THE HP DID NOT NOTICE ANYTHING UNUSUAL WITH THE SUPPLIES AT USE THAT NIGHT. THE HP HAD ALSO NOTIFIED HER NURSE REGARDING THE ALARM. THE HP WAS CONTINUING THERAPY WITHOUT ANY OTHER COMPLICATIONS. NO FURTHER INFORMATION WAS PROVIDED. 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 H11B19052

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE