BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2222818 · Received August 25, 2011

    Report

    Report Number
    1423500-2011-11240
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 1, 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 2240 (AIR IN SET) OCCURRED WAS NOT CONFIRMED; PER THE COMPLAINT INFORMATION THE CAUSE OF THE SYSTEM ERROR 2240 WAS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE BECAUSE THE PATIENT LINE BECAME INADVERTENTLY DISCONNECTED FROM THE TRANSFER SET. THE ASSIGNABLE CAUSE WAS DUE TO USE ERROR - PATIENT DISCONNECTED FROM SET. A LABEL REVIEW WAS PERFORMED AND THE REVIEW FOUND THE LABELING ADEQUATE FOR THE USER ERROR IN THE COMPLAINT. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT RETURNED TO BAXTER, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF 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 DRAIN 5 OF 6. THE HOME PATIENT (HP) REPORTEDLY FELL OUT OF THE BED AND THE LINE DISCONNECTED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM TO THE HP'S SON AND ASSISTED TO CLEAR THE ALARM. THE HP WOULD STOP THERAPY UNTIL CONTACT WAS MADE WITH NURSE. THERE WAS PATIENT INVOLVEMENT. THERE WAS NO INJURY OR MEDICAL INTERVENTION REPORTED AS A RESULT OF THIS EVENT. DURING A FOLLOW UP PHONE CALL BY PRODUCT SURVEILLANCE TO THE CAREGIVER (CG) ON (B)(6) 2011 REGARDING THE ALARM, IT WAS REVEALED THAT THE ALARM OCCURRED DUE TO A DISCONNECTION. THE CG STATED THERE WERE NO DEFECTS ON THE SUPPLIES. THE CG STATED THE ALARM OCCURRED BECAUSE OF THE WAY THEY DISCONNECTED THE HP. THE CG STATED THE HP HAD NO INJURY OR MEDICAL INTERVENTION FROM THIS INCIDENT. THE CG COULD NOT PROVIDE FURTHER DETAILS.

    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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR HOMECHOICE