BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 2052241 · Received April 12, 2011

    Report

    Report Number
    1423500-2011-04402
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 18, 2011
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORT OF A CONNECTION ISSUE WAS NOT CONFIRMED AND THE CAUSE WAS NOT IDENTIFIED BECAUSE THE PATIENT DID NOT DESCRIBE ANY TYPE OF USE ERROR THAT MIGHT HAVE CAUSED THIS ISSUE. PER THE CAREGIVER A SUPPLY BAG BECAME DISCONNECTED. HOWEVER WITHOUT A SAMPLE TO EVALUATE BAXTER WAS UNABLE TO IDENTIFY A PRODUCT ISSUE THAT MIGHT HAVE CAUSED THE BAG TO BECOME DISCONNECTED. THE LOT NUMBER IS UNKNOWN, THEREFORE A BATCH REVIEW WAS NOT PERFORMED.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL MDR WAS INCORRECT WITH BRAND NAME OF ASKU. 510K STATEMENT MISSING FROM INITIAL MDR A 510K NUMBER WILL NOT BE PROVIDED IN THE MDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED AND THE LOT NUMBER WAS NOT KNOWN BY THE PATIENT, THEREFORE, DEVICE EVALUATION CANNOT BE PERFORMED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S INVESTIGATION.

    Description of Event or Problem · 1

    A CAREGIVER AND PATIENT CONTACTED GLOBAL TECHNICAL SERVICES (GTS) REGARDING ASSISTANCE WITH STARTING OVER WITH NEW SUPPLIES WHILE USING THE HOMECHOICE (HC) DURING DWELL 1 OF 6. THE CAREGIVER STATED THAT A SUPPLY BAG DISCONNECTED. GTS HAD THE CAREGIVER CYCLE POWER AND END THERAPY TO REMOVE THE SET. THE CAREGIVER ELECTED TO START OVER WITH NEW SUPPLIES. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE PRO