BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2103181 · Received May 25, 2011

    Report

    Report Number
    1423500-2011-06516
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 2, 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). DURING INVESTIGATION BY BAXTER THIS INCIDENT WAS DETERMINED TO BE CAUSED BY USE ERROR AND THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION. THEREFORE, A BATCH REVIEW AND SAMPLE EVALUATION WILL NOT BE CONDUCTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT FOR A SYSTEM ERROR 2240 (AIR IN SET) WAS NOT CONFIRMED; HOWEVER, PER THE COMPLAINT INFORMATION THE CAUSE OF THE ALARM IS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE BECAUSE THE PATIENT EXTENSION LINE WAS CONNECTED AFTER PRIMING WAS COMPLETE. LABELING FINDS THE LABELING ADEQUATE FOR THE USE 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 CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER AND REPORTED RECEIVING SYSTEM ERROR 2240 (AIR IN LINE) ALARM ON THE HOMECHOICE (HC) MACHINE DURING DRAIN 3 OF 5. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HOME PATIENT (HP) TO CYCLE POWER. THE HP WAS MORE THAN HALFWAY THROUGH THERAPY, SO HE WAS GOING TO DISCONNECT FOR THE NIGHT AND CALL THE NURSE IN THE MORNING TO SEE IF HE SHOULD DO MANUAL THERAPY. THE HP STATED THAT HE CONNECTS HIS PATIENT LINE EXTENSION WHEN HE CONNECTS HIMSELF. THE TSR EXPLAINED THAT IT SHOULD ALWAYS BE CONNECTED DURING PRIME SO THAT IT CAN FILL WITH FLUID BEFORE HE CONNECTS. BAXTER PRODUCT SURVEILLANCE CONTACTED THE CLINIC RECEPTIONIST ON (B)(6) 2011. A DETAILED MESSAGE WAS LEFT TO NOTIFY THE NURSE THAT THE PATIENT CONNECTS THE EXTENSION LINE AFTER PRIMING. THE RECEPTIONIST STATED SHE WOULD FORWARD THE MESSAGE TO THE NURSE. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

    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 67 YR HOMECHOICE