BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2122164 · Received June 13, 2011

    Report

    Report Number
    1423500-2011-07524
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 25, 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). THE SAMPLE IS NOT AVAILABLE AND THE LOT NUMBER IS UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) WAS NOT CONFIRMED. THE CAUSE OF THE SYSTEM ERROR 2240 WAS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE AFTER THE PATIENT DISCONNECTED THE PATIENT LINE FROM THE TRANSFER SET. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE POTENTIAL USE ERROR IN THIS COMPLAINT. BAXTER 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

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT A SYSTEM ERROR (SE) 2240 WHICH OCCURRED ON HOME CHOICE (HC) DURING USE DURING THERAPY. THE BAXTER TECHNICAL REPRESENTATIVE (TSR) EXPLAINED THE SE AND HAD THE HOME PATIENT (HP) CYCLE POWER OFF AND ON AND GOT SE 2367. THE TSR EXPLAINED TO THE HP THE PROPER PROCEDURES FOR WHEN SHE WANTS TO DISCONNECT. THE TSR HAD THE HP CYCLE POWER OFF AND ON AGAIN. THE SE DID NOT REPEAT. THE HC WAS AT "PRESS GO TO START" . THERE WAS PATIENT INVOLVEMENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. (B)(4) CONTACTED THE HP ON (B)(6) 2011 REGARDING THE SYSTEM ERROR 2240 ALARM. PER THE HP, SHE DISCONNECTED TO GO TO THE KITCHEN AND WHEN SHE GOT BACK SHE DIDN'T THINK ABOUT RECONNECTING. THE HC ALARMED AND THEN THE HP RECONNECTED. THE WRITER ADVISED THE HP THAT IT IS NOT RECOMMENDED THAT THE HP RECONNECT AFTER THE HC HAS MOVED TO ANOTHER CYCLE AS THE ALARM MEANS THERE IS AIR IN THE SET. THE HP UNDERSTOOD THE ALARM. THE HP STATED SHE WAS IN THE FOURTH CYCLE, SO SHE DID NOT START OVER WITH NEW SUPPLIES AND SHE DID CONTACT HER PD RN ABOUT THE ALARM. THE HP STATED SHE RESUMED THERAPY THE FOLLOWING NIGHT ON THE CYCLER. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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 55 YR HOMECHOICE