BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2133956 · Received June 20, 2011

    Report

    Report Number
    1423500-2011-07851
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 26, 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). CORRECTION: THE REPORTED ALARM WAS AT SYSTEM ERROR (SE) 2267.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT SURVEILLANCE CONTACTED REGISTERED NURSE ON (B)(4) 2011 REGARDING THE SYSTEM ERROR 2267 ALARM. THE NURSE STATED THAT SHE WAS NOT AWARE OF THE HOME PATIENT HAVING THE SYSTEM ERROR ALARM. THE NURSE WAS REMINDED THAT IT WAS CONSIDERED IMPROPER TECHNIQUE TO LEAVE AN UNUSED LINE UNCLAMPED. THE NURSE WILL REVIEW WITH THE PATIENT PROPER TECHNIQUE AT THEIR NEXT VISIT. THE NURSE STATED THAT THE PATIENT WAS DOING FINE AND CONTINUING THERAPY WITHOUT ISSUES. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE PATIENT DIALYSIS PRODUCTS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED. THIS COMPLAINT FOR A SYSTEM ERROR 2267 (AIR IN SET) THAT OCCURRED DURING FILL 4 OF 5 WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE CAUSE WAS DETERMINED TO BE THE RESULT OF THE PATIENT LEAVING AN OPEN CLAMP ON AN UNUSED SUPPLY LINE. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. THE BATCH REVIEW WAS NOT PERFORMED BECAUSE THE LOT NUMBER IS UNKNOWN. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ANY FURTHER INFORMATION BECOME AVAILABLE, A FOLLOW UP WILL BE SENT.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR (SE) 2240 ALARM THAT OCCURRED ON THE HOME CHOICE (HC) MACHINE DURING FILL 4 OF 5. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE SE ALARM INDICATES AIR ENTERED THE SET UP AND FURTHER ASSISTED WITH TROUBLESHOOTING. THE HP CONFIRMED A CLAMP ON AN UNUSED LINE WAS OPEN. THE TSR ASSISTED THE HP TO CYCLE POWER TO CLEAR THE ALARM. THE HP CONFIRMED TO ADVISE THE HP OF THE INCIDENT. 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 61 YR HOMECHOICE PRO