BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1736056 · Received June 24, 2010

    Report

    Report Number
    1423500-2010-01284
    Event Type
    Malfunction
    Date Received
    June 24, 2010
    Date of Event
    June 8, 2010
    Report Date
    June 8, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN ENGINEERING QUALITY REVIEW WAS COMPLETED FOR THIS REPORT OF A SYSTEM ERROR 2240 (AIR IN SET). THE REPORT 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 AFTER THE SPIKE CONNECTOR DISCONNECTED FROM ONE OF THE SUPPLY BAGS. THE HP STATED THAT BAG HAD COME OUT OFF THE SPIKE; HE ACCIDENTALLY CONNECTED THE WRONG LINE TO THE WRONG BAG. THE PATIENT STATED HE USES A CXD DEVICE SO WHEN HE REALIZED HE CONNECTED THE WRONG LINE, HE MANUALLY CORRECTED AND MUST NOT HAVE MADE A SECURE CONNECTION BECAUSE THE SPIKE FELL OUT. THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE INSTRUCTS USERS TO CHECK THE CONNECTIONS FOR SECURE FIT. THIS REVIEW FINDS THE LABELING ADEQUATE FOR THE POTENTIAL USE ERROR(S) 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).

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Description of Event or Problem · 1

    THE HOME PATIENT (HP) REPORTED THAT A BAG HAD COME OFF THE SPIKE. THE TECHNICAL SERVICE REPRESENTATIVE ADVISED THE HP TO RECYCLE THE MACHINE. THE TSR INFORMED THE HP TO USE MANUAL BAGS OR START OVER AGAIN USING NEW SUPPLIES. ON (B)(6) 2010 PRODUCT SURVEILLANCE SPOKE WITH THE HP WHO STATED HE ACCIDENTALLY CONNECTED THE WRONG LINE TO THE WRONG BAG. THE PATIENT STATED HE USES A CXD DEVICE SO WHEN HE REALIZED HE CONNECTED THE WRONG LINE, HE MANUALLY CORRECTED AND MUST NOT HAVE MADE A SECURE CONNECTION BECAUSE THE SPIKE FELL OUT AND THE MACHINE ALARMED. THE PATIENT STATED HE WAS FEELING FINE AND DOING OKAY WITH THERAPY. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING A ZIMMER DERMATOME BLADE, THE BLADE CUT DEEPER ON ONE SIDE AND THINNER ON THE OTHER WHICH CAUSED IMPAIRED HEALING FROM AN ESTHETICAL POINT OF VIEW.

    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 55 YR