BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3 PRONG

    MDR report key: 1935917 · Received December 22, 2010

    Report

    Report Number
    1423500-2010-07148
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    December 3, 2010
    Report Date
    December 3, 2010
    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 FOR A SYSTEM ERROR 2240 (AIR IN SET) OCCURRED DURING INITIAL DRAIN WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE; HOWEVER, PER THE COMPLAINT INFORMATION THE CAUSE OF THE SE 2240 IS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE AFTER INCOMPLETE PRIMING. THE HOME PATIENT (HP) STATED THE PATIENT LINE DID NOT PRIME COMPLETELY WHEN THE HP CONNECTED AND STARTED THERAPY. THE HP STATED THAT WAS THE CAUSE OF THE ALARM. 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). THE DEVICE WAS DISCARDED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED GLOBAL TECHNICAL SERVICE (GTS) REGARDING A SYSTEM ERROR 2240 THAT APPEARED ON THE HOME CHOICE (HC) DURING THE INITIAL DRAIN. THE HOME PATIENT (HP) STATED THE PATIENT LINE DID NOT PRIME COMPLETELY WHEN THE HP CONNECTED AND STARTED THERAPY AND THE HP STATED THAT SEEMED TO HAVE BEEN THE CAUSE OF THE ALARM. GTS ADVISED THE HP TO START OVER WITH NEW SUPPLIES AND THE HP WOULD CALL BACK WITH ANY PROBLEMS. PROPER PROCEDURES PER THE USER MANUAL WERE REVIEWED WITH THE CALLER. BAXTER PRODUCT SURVEILLANCE SPOKE WITH THE HOME PATIENT'S (HP) NURSE ON (B)(6) 2010. IT WAS EXPLAINED THAT THE PATIENT LINE WAS NOT PRIMED COMPLETELY WHEN THE HP CONNECTED. THE HP'S NURSE SAID THAT THE HP DID NOT HAVE INJURY OR MEDICAL INTERVENTION SINCE THE REPORTED PROBLEM. THE HP'S NURSE STATED SHE WAS NOT AWARE OF THIS PARTICULAR ALARM BUT THAT HE HAS HAD COMPLICATIONS THAT ARE NOT RELATED TO THERAPY; JUST HIS BODY. NO ADDITIONAL INFORMATION COULD BE OBTAINED. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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 78 YR HOMECHOICE APD CYCLER