BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1914769 · Received December 3, 2010

    Report

    Report Number
    1423500-2010-06514
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 10, 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). AN ENGINEERING QUALITY REVIEW WAS COMPLETED FOR THIS REPORT OF A CONNECTION ISSUE. THE REPORTED CONDITION WAS NOT CONFIRMED DUE TO LACK OF PRODUCT SAMPLE. A BATCH REVIEW WAS NOT PERFORMED BECAUSE LOT INFORMATION WAS UNKNOWN. BASED ON THE INFORMATION OBTAINED FROM BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THE INCIDENT WAS DUE TO A SUPPLY BAG FALLING AND DISCONNECTING. THIS REPORT IS POTENTIALLY RELATED TO THE PATIENT NOT PLACING THE BAG IN AN APPROPRIATE LOCATION. THE LABELING REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A BAG THAT FELL AND BECAME DISCONNECTED WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE, DURING DWELL 3 OF 5. NO SYSTEM ERROR ALARM OCCURRED. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE CAREGIVER (CG) CYCLE POWER TO THE HC OFF AND THEN ON TO END THERAPY EARLY. THE CG WAS THEN STARTING THE HOME PATIENT(HP) OVER WITH NEW SUPPLIES. THE HC WAS OPERATIONAL. THE SOLUTION TO THIS ISSUE WAS PROVIDED OVER THE PHONE AND A SWAP OF THE DEVICE WAS NOT NECESSARY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. THE WRITER CONTACTED THE CG ON (B)(6) 2010 REGARDING THE DISCONNECTION OF THE BAG. THE CG STATED THEY USE A THREE TIERED CART FOR THERAPY. THE CG STATED SHE HAS BAGS ON THE SECOND AND THIRD SHELF OF THE CART. THE CG DID NOT HAVE AN EXPLANATION BESIDES USE ERROR THAT THE BAG FELL OFF THE CART AND DISCONNECTED. THE CG STATED THE HP RESUMED THERAPY AND WAS CURRENTLY USING THE CYCLER. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR