BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1802061 · Received August 16, 2010

    Report

    Report Number
    1423500-2010-02565
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    July 26, 2010
    Report Date
    July 27, 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 4 OF 15 DURING A FOLLOW UP CALL TO THE HOME PATIENT (HP) BY PRODUCT SURVEILLANCE, THE HP REPORTED THAT FOUR (4) CASSETTES WERE FOUND WITH THE TUBING CRUSHED AND UNUSABLE. ON (B)(6) 2010 PRODUCT SURVEILLANCE SPOKE WITH THE HP WHO CONFIRMED THAT THE DAMAGED CASSETTES WERE NOT USED; THE DAMAGE WAS NOTED PRIOR TO THERAPY. ON (B)(6) 2010 PRODUCT SURVEILLANCE SPOKE WITH THE HP WHO STATED THE EXTERNAL BOX OF THIS PRODUCT LOT WAS NOT DAMAGED. THE HP STATED APPROXIMATELY HALF OF THE CASE OF THE CASSETTES (15) HAD TO BE DISCARDED DUE TO CRUSHED TUBING. THE HP STATED THE 15 CASSETTES HE DISPOSED OF ALL HAD 'U' SHAPE DAMAGE AND THE TUBING WAS UNUSABLE. THE HP STATED THERE WERE A VARIETY OF LINES DAMAGED; THERE WAS NO TREND OF 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. NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BIOMED FROM THE NURSE MGR THAT ON MONDAY, (B)(6), THE PT WAS SCHEDULED FOR OPEN HEART SURGERY. THE INTRA-AORTIC BALLOON (IAB) WAS INSERTED VIA THE LEFT FEMORAL ARTERY. DURING SURGERY, THE INTRA-AORTIC BALLOON PUMP (IABP) ALARMED HELIUM LEAK. THE PT RECEIVED IABP THERAPY UNTIL WEDNESDAY, (B)(6). AS THE MD WAS REMOVING THE IAB FROM THE PT, HE MET RESISTANCE. IT WAS NOTED THAT A PIECE OF THE MEMBRANE FROM THE IAB REMAINED IN THE PT. THE PT WAS TAKEN TO SURGERY AND THE PIECE OF MEMBRANE WAS REMOVED. THERE WAS NO REPORTED PT DEATH. MEDICAL/SURGICAL WAS REQUIRED. THE PT UNDERWENT A THROMBECTOMY, PATCH ANGIOPLASTY OF THE LEFT COMMON FEMORAL ARTERY/SUPERFICIAL FEMORAL ARTERY AND RETRIEVAL OF THE BALLOON FRAGMENT. HE HAS DONE WELL AND HIS DISTAL EXTREMITY IS FINE. THE PT OUTCOME IS LISTED AS FINE AND THE PT IS IN THE CARDIOTHORACIC INTENSIVE CARE UNIT (CTICU). ADD'L INFO RECEIVED FROM BIOMED ON 11/1/2010 STATED THAT THE IAB WAS INSERTED USING A SHEATH. "THE IAB WAS INSERTED ON (B)(6) IN THE EVENING. IT WAS PLACED ON 1:4 ON (B)(6) AT 7 AM AND REMOVED ON (B)(6) AT 8 AM."

    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