BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1871929 · Received October 16, 2010

    Report

    Report Number
    1423500-2010-04509
    Event Type
    Malfunction
    Date Received
    October 16, 2010
    Date of Event
    September 23, 2010
    Report Date
    September 23, 2010
    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). THE SAMPLE IS NOT AVAILABLE, THEREFORE, BAXTER CANNOT DETERMINE ROOT CAUSE. SINCE THE LOT NUMBER IS UNKNOWN A BATCH REVIEW CANNOT BE PERFORMED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT OF A SYSTEM ERROR 2240 WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE; HOWEVER, BASED ON THE INFORMATION OBTAINED DURING BAXTER'S INVESTIGATION, THIS INCIDENT WAS DETERMINED TO BE CAUSED BY AIR BEING SUCKED INTO THE DISPOSABLE BECAUSE THERE WAS AN OPEN CLAMP ON AN UNUSED SUPPLY LINE DURING THERAPY. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE INSTRUCTS THE PATIENT TO CLOSE ALL CLAMPS ON UNUSED FLUID LINES SECURELY. THIS REVIEW FOUND THE LABELING ADEQUATE FOR THE POTENTIAL USE 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 THROUGH (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER AND REPORTED RECEIVING A SYSTEM ERROR 2240 (AIR IN LINE) ALARM ON THE HOMECHOICE (HC) MACHINE DURING DWELL 1. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HOME PATIENT (HP) AND VERIFIED THAT THE HP HAD ACCIDENTALLY LEFT THE BLUE CLAMP LINE OPEN DURING THERAPY, WHICH IS AN UNUSED SUPPLY LINE. THE TSR ADVISED THE HP TO START OVER WITH NEW SUPPLIES. PRODUCT SURVEILLANCE CONTACTED THE NURSE ON (B)(4) 2010 REGARDING THE OPEN CLAMP. THE NURSE STATED THAT THE PATIENT RESUMED THERAPY SUCCESSFULLY. THE PATIENT DID NOT REPORT THIS EVENT, HOWEVER, THE PATIENT HAS BEEN SEEN AND IS DOING FINE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3-PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR