BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1932449 · Received December 17, 2010

    Report

    Report Number
    1423500-2010-07024
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 22, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE CUSTOMER THE SAMPLE WAS DISCARDED AND THE LOT NUMBER IS UNKNOWN, THEREFORE, NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. A FOLLOW-UP REPORT WILL BE FILED SHOULD ANY SIGNIFICANT SUPPLEMENTAL INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE; HOWEVER, PER THE COMPLAINT INFORMATION THE CAUSE OF THE SE 2240 IS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE AFTER THE PATIENT DISCONNECTED THE PATIENT LINE FROM THE TRANSFER SET. THE HP SAID THAT SHE DISCONNECTED DRAIN BAG AND ADDED ANOTHER DRAIN BAG. THE HP THEN SAID THAT SHE DID NOT DISCONNECT DURING THERAPY. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT 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. 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 REGARDING A SYSTEM ERROR 2240 (AIR IN LINE) ALARM THAT APPEARED ON THE HOMECHOICE (HC) DISPLAY DURING DWELL 1. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM AND THE CORRECT DISCONNECT PROCEDURE TO THE HOME PATIENT (HP). THE HP SAID THAT SHE HAD TO DISCONNECT BECAUSE, DRAIN LEAKED. THE HP SAID THAT SHE DISCONNECTED DRAIN BAG AND ADDED ANOTHER DRAIN BAG. THE TSR ADVISED TO FOLLOW UP WITH THE NURSE. PROPER PROCEDURES PER THE USER MANUAL WERE REVIEWED WITH THE HP. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL REPORT.

    Description of Event or Problem · 1

    DURING A FOLLOW UP PHONE CALL BY PRODUCT SURVEILLANCE (PS) TO THE HOME PATIENT (HP), THE HP DID NOT PROVIDE ANY ADDITIONAL INFORMATION. THE PS ASSOCIATE TRIED TO ASK THE HP ABOUT THE LEAK IN THE DRAIN BAG. THE HP STATED THAT THE ISSUE OCCURRED DURING DWELL. THE HP STATED THAT SHE WAS FINE AND DID NOT PROVIDE ANY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 HC CYCLER