BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2132612 · Received June 17, 2011

    Report

    Report Number
    1423500-2011-07749
    Event Type
    Malfunction
    Date Received
    June 17, 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 DEVICE WAS NOT AVAILABLE FOR EVALUATION. THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. PER THE COMPLAINT INFORMATION THE MOST PROBABLE 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. 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).

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED 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.

    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 DRAIN 2 OF 3. THE HOME PATIENT (HP) WAS DISCONNECTED, AT THE TIME OF THE ALARM SHE RECONNECTED BACK. THE BAXTER TECHNICAL REPRESENTATIVE (TSR) EXPLAINED THE ALARM. THE TSR ASSISTED THE HP TO CLEAR THE ALARM BY TURNING THE HC OFF AND ON AND SE 2367 OCCURRED. THE TSR HAD THE HP TURNOFF AND ON AND THE HC CAME BACK TO "PRESS GO TO START". THE HP WILL FINISH WITH MANUAL BAG. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. PRODUCT SURVEILLANCE CONTACTED THE HP ON (B)(6) 2011 REGARDING THE SYSTEM ERROR 2240 ALARM. PER THE HP, SHE DISCONNECTED TO USE THE BATHROOM AND CAME BACK AND RECONNECTED. THE HP STATED THE HC WAS ALARMING. THE WRITER EXPLAINED TO THE HP THAT ONCE THE HC HAS MOVED TO ANOTHER CYCLE, THAT IT IS NOT RECOMMENDED THAT THE HP RECONNECT AND THAT THERE WAS AIR PULLED INTO THE SET. THE HP UNDERSTOOD. THE HP STATED SHE DID A MANUAL EXCHANGE AND FOLLOWED UP WITH HER NURSE 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 44 YR HOMECHOICE