BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1812702 · Received August 24, 2010

    Report

    Report Number
    1423500-2010-02810
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 16, 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) A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE. THE SAMPLE WAS DISCARDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). AN ENGINEERING QUALITY REVIEW WAS COMPLETED FOR THIS REPORT OF DAMAGED TUBING. THE REPORT WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE AND THE ROOT CAUSE WAS UNDETERMINED. A BATCH REVIEW WAS PERFORMED ON THE ASSOCIATED LOT WITH NO ISSUES NOTED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THIS COMPLAINT FILE ADDRESSES PRODUCT SAMPLE 7 OF 15 REPORTED (B)(4) 2010. DURING A FOLLOW UP CALL FOR A RELATED COMPLAINT FILE, THE HOME PATIENT (HP) REPORTED A APPROXIMATELY HALF OF THE CASE OF THE CASSETTES (15) HAD TO BE DISCARDED DUE TO CRUSHED TUBING. THE HP CONFIRMED THE EXTERNAL BOX OF THIS PRODUCT LOT WAS NOT DAMAGED. THE HP STATED HE HAD BEEN INSTRUCTED THAT IF THE TUBING HAD A 'V' SHAPE, IT COULD BE WORKED OUT AND PRODUCT USED. THE HP STATED IN THIS PARTICULAR LOT, THE 15 CASSETTES HE DISPOSED OF ALL HAD 'U' SHAPE DAMAGE AND THE TUBING WAS UNUSABLE. THE HP STATED IT WAS A VARIETY OF LINES DAMAGED; THERE WAS NO TREND IN SPECIFIC LINE. HOWEVER, THE HP STATED ALL LINES WERE CRUSHED ABOVE THE CLAMPS. THE HP STATED IT APPEARED THE CLAMPS CAUSED THE DAMAGE TO THE TUBING BY HOW THE CASSETTES WERE PACKAGED. THE HP STATED HE HAS HAD NO ISSUE WITH HIS NEW LOT OF SUPPLIES AND HAS SELDOM HAD ISSUES WITH PRODUCT IN THE PAST. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION.

    Description of Event or Problem · 1

    USING A LINVATEC ABLATOR FOR A SHOULDER PROCEDURE, PATIENT RECEIVED A PAD BURN ON THE RIGHT CALF. BURN OCCURED ON THE TOP PORTION OF WHERE PAD WAS PLACED. THERE WERE 2 BURNS IN THE AREA, BURN WAS DESCRIBED AS 3RD DEGREE, WIDTH - 3 INCHES, HEIGHT 1/2 INCH. THE INITIAL REPORTER STATED THE ABLATOR (CAT#: IA-2379-FC) IFU CALLS OUT FOR A SINGLE DISPERSIVE PAD, AND THE PAD USED WAS A DUAL DISPERSIVE.

    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 H10E29048

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR