BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2172777 · Received July 22, 2011

    Report

    Report Number
    1423500-2011-09313
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 26, 2011
    Report Date
    June 26, 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). SHOULD ANY FURTHER INFORMATION BECOME AVAILABLE, A FOLLOW UP WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR (SE) 2240 (AIR IN SET) WAS CONFIRMED AND THE CAUSE IS DUE TO USE ERROR. PER THE COMPLAINT INFORMATION THE CAUSE OF THE SE 2240 IS DUE TO THE PATIENT HAVING A CLAMP OPEN ON AN UNUSED SUPPLY LINE. THE HP STATED THERE WAS AN OPEN CLAMP ON AN UNUSED LINE. THERE WAS NO ALLEGATION OF PRODUCT MALFUNCTION REPORTED BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION. LABEL REVIEW WAS PERFORMED AND THE REVIEW FOUND THE LABELING ADEQUATE FOR THE USER ERROR IN THE COMPLAINT. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR (SE) ALARM THAT OCCURRED ON THE HOME CHOICE (HC) MACHINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP TO REVIEW THE ALARM LOG; THE HP CONFIRMED A SE 2240 ALARM OCCURRED. THE TSR EXPLAINED THE ALARM INDICATES AIR ENTERED THE SET UP. THE HP STATED THERE WAS AN OPEN CLAMP ON AN UNUSED LINE. THE TSR ASSISTED THE HP TO RETRIEVE THE CASSETTE AND ADVISED TO LET THE RN KNOW ABOUT THE ALARM. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. ON (B)(4) 2011, PRODUCT SURVEILLANCE CONTACTED THE REGISTERED NURSE (RN) REGARDING THE ALARM. THE RN WAS AWARE OF THE INCIDENT. THE RN WAS PROVIDED FURTHER DETAILS REGARDING THE USE ERROR FOR RETRAINING PURPOSES. THERE WERE NO FURTHER DETAILS PROVIDED.

    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 76 YR HOMECHOICE