BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1801877 · Received August 16, 2010

    Report

    Report Number
    1423500-2010-02546
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    July 25, 2010
    Report Date
    July 25, 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). THE DEVICE WAS DISCARDED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) DURING DWELL 4 OF 5 WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. BASED ON THE INFORMATION OBTAINED DURING BAXTER'S INVESTIGATION, THIS INCIDENT WAS DETERMINED TO BE DUE TO AIR BEING SUCKED INTO THE DISPOSABLE AFTER THE PATIENT DISCONNECTED FROM THE HOME CHOICE (HC) AND TOOK TOO LONG TO COME BACK AND THEN RECONNECTED WHEN THE ALARM OCCURRED. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE POTENTIAL USE ERROR IN THIS 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). BAXTER CORPORATE PRODUCT SURVEILLANCE CONTACTED THE PATIENT REGARDING THIS SYSTEM ERROR 2240 ALARM ON (B)(6) 2010. THE PATIENT CLARIFIED THAT THE CAUSE OF THE ALARM WAS THAT HE HAD DISCONNECTED FROM THE HOME CHOICE (HC) AND THAT HE TOOK TOO LONG TO COME BACK AND RECONNECT TO HIS LINE. MORE SPECIFIC TO THE INCIDENT, THE PATIENT ALSO STATED THAT HE INITIATED A CALL TO TECHNICAL SERVICES THE NIGHT THE ALARM OCCURRED, WAS ABLE TO START OVER WITH NEW SUPPLIES TO RESUME HIS THERAPY AND NOW KNOWS THE PROPER PROCEDURE. ADDITIONALLY, THE PATIENT STATED THAT HE DID NOT NOTIFY HIS PD NURSE ABOUT THE ALARM. WHEN WE INQUIRED ABOUT THE LOT NUMBERS OF THE PRODUCTS HE WAS USING, HE STATED THAT HE HAD DISCARDED THE SUPPLIES AFTER THERAPY, DID NOT KNOW THE LOT NUMBERS OR THE DATE OF SHIPMENT OR DELIVERY. OVERALL, THE PATIENT DID NOT ALLEGE ANY HARM, INJURY OR NEED FOR MEDICAL ATTENTION DUE TO THE INCIDENT AND CONTINUES TO USE THE HOMECHOICE FOR HIS PERITONEAL DIALYSIS THERAPY TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR 2240 (AIR IN SET) ALARM ON THE HOMECHOICE DURING DWELL 4 OF 5. THE HOME PATIENT (HP) WAS CONNECTED AND REPORTED HAD NOT DISCONNECTED PRIOR TO THE ALARM. THERE WERE NO OBVIOUS SIGN OF AN AIR LEAK FROM ANY OF THE BAGS. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD HP CLOSE ALL CLAMPS AND CYCLED POWER TO CLEAR ALARM. HP WILL DISCONNECT AND REMOVE CASSETTE AT "LOAD THE SET". HP WILL DO A MANUAL EXCHANGE TO FINISH THE THERAPY AND WILL CALL REGISTERED NURSE FOR ANY CLINICAL ADVICE. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 1

    DURING A REVIEW OF THE EVENT HISTORY OF ANOTHER REPORT, FOR A COLLEAGUE INFUSION PUMP, IT WAS DISCOVERED THAT FAILURE CODE 808:02 OCCURRED ONCE DURING INFUSION WHICH CAUSED AN INTERRUPTION DURING DELIVERY ON (B)(6) 2010. THERE WAS NO ADVERSE EVENT, PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. THERE IS NO FURTHER COMPLAINT INFORMATION AVAILABLE. THE USER INTERFACE MODULE MASTER SOFTWARE VERSION IS 6.13.90, CATEGORIZED AS REMEDIATED.

    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 48 YR