BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2032066 · Received March 28, 2011

    Report

    Report Number
    1423500-2011-03760
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    March 5, 2011
    Report Date
    March 5, 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 WAS NOT CONFIRMED; 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. THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. THIS REVIEW FINDS THE LABELING 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).

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE CUSTOMER THE SAMPLE WAS DISCARDED AND THE LOT NUMBER WAS UNKNOWN, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR (SE) 2240 (AIR IN LINE) ALARM THAT APPEARED ON THE HOMECHOICE (HC) DISPLAY DURING DRAIN 4 OF 5. THE HOME PATIENT (HP) STATED THAT SHE DISCONNECTED HERSELF TO USE THE BATHROOM. THE HP PUT A MINI CAP ON THE CATHETER, BUT DID NOT PUT A FLEXI CAP ON THE PATIENT LINE. THE HP RECONNECTED HERSELF AND PRESSED GO. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED TO THE HP WHEN DISCONNECTING, SHE NEEDS TO CAP OFF BOTH THE CATHETER AND PATIENT LINE. THE TSR ADVISED SHE WOULD NEED TO START OVER WITH NEW SUPPLIES OR DO A MANUAL EXCHANGE. THE HP WOULD START OVER WITH NEW SUPPLIES SINCE SHE DOES NOT HAVE MANUAL SUPPLIES. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL REPORT. DURING FOLLOW UP THE HP STATED THAT THE ISSUE WAS RESOLVED. THE NURSE EXPLAINED TO THE HP THE PROPER PROCEDURES FOR CONNECTING AND DISCONNECTING WHILE USING THE CYCLER. PER HP, SHE DID NOT RECEIVE ANY INJURY OR MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. THE HP STATED THAT SHE IS DOING FINE AND CONTINUING THERAPY WITHOUT ISSUES. THE HP CONTINUED THERAPY USING NEW SUPPLIES. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE HP'S DIALYSIS PRODUCTS. NO FURTHER INFORMATION WAS 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 75 YR HC CYCLER