BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT 2 WAVE JAPANESE

    MDR report key: 2396285 · Received December 1, 2011

    Report

    Report Number
    1219856-2011-00428
    Event Type
    Malfunction
    Date Received
    December 1, 2011
    Date of Event
    November 8, 2011
    Report Date
    November 29, 2011
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WILL NOT BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    REFERENCE MDR #1219856-2011-00427 FOR THE RELATED INTRA-AORTIC BALLOON REPORT INVOLVING THE SAME PT. IT WAS REPORTED THAT THE EVENT INVOLVED A FEMALE PT WHILE IN THE CATH LAB. AS SOON AS THE CAL KEY WAS CONNECTED TO THE PUMP, BEFORE THE INTRA-AORTIC BALLOON (IAB) INSERTION, THE CAL KEY WAS NOT RECOGNIZED BY THE PUMP, BUT THE FOS CONNECTED SUCCESSFULLY. AFTER SEVERAL ATTEMPTS OF CONNECTING THE CAL KEY, THE PUMP FINALLY RECOGNIZED IT. ANOTHER IAB (ANOTHER COMPANY'S 9 FR. SHEATH) WAS INSERTED THROUGH THE SAME SHEATH VIA THE SAME INSERTION SITE (RIGHT FEMORAL ARTERY) USING THE SAME SPRING WIRE GUIDE (SWG) WITHOUT ISSUES. THE MD NOTICED THE FIBEROPTIX SENSOR (FOS) WAVEFORM WAS LARGELY DRIFTING AND THE VALUES OF THE NUMERICAL VALUES OF THE FOS WAVEFORM WAS BETWEEN 300 AND 350. AS A RESULT, THE PUMP WAS SWITCHED OUT FOR A (B)(4) MEDICAL PUMP. THERE WAS NO MEDICAL/SURGICAL INTERVENTION REQUIRED. NO DELAY OR INTERRUPTION IN THERAPY WAS NOTED. THERE WAS NO REPORT OF PT DEATH, INJURY OR COMPLICATIONS. THE PT OUTCOME IS GOOD. THE PUMP WILL BE CHECKED IN (B)(4). SERVICE FINDINGS OF THE PUMP, INITIAL INSPECTION BY (B)(4). THE FIRST FOS TESTER WAS CONNECTED TO AN IN HOUSE AUTOCAT WAVE TO MAKE SURE THE FIRST FOS TESTER WORKED PROPERLY. THE FIRST TESTER WAS THEN CONNECTED TO THE PUMP AND FOS WAS READ BY THE PUMP. CAL KEY 1ST ATTEMPT READ, 2ND ATTEMPT NOT READ. THE SECOND TESTER WAS CONNECTED TO THE SAME PUMP AND FOS WAS READ BY THE PUMP. CAL KEY 1ST ATTEMPT READ 2ND ATTEMPT NOT READ. IT APPEARED THAT THE PUMP BROKE BOTH FOS TESTERS. FOS PCB (PRINTED CIRCUIT BOARD) CHECKOUT. THE FOS BOARD OF THE PUMP WAS REPLACED WITH AN IN-HOUSE FOS BOARD. THE THIRD FOS TESTER WAS CONNECTED TO THE PUMP WITH THE IN-HOUSE BOARD, THE PUMP READ THE FOS TESTER. THE TESTER WAS REPEATEDLY DISCONNECTED/RECONNECTED TO THE PUMP SUCCESSFULLY AND READ THE FOS AND CAL KEY EACH TIME. REPLACEMENT OF THE FOS PCB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOCAT 2 WAVE JAPANESE INTRA-AORTIC BALLOON PUMP PRODUCTS DSP ARROW INTERNATIONAL INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR (B)(4) MEDICAL INTRA-AORTIC BALLOON PUMP| INTRA-AORTIC BALLOON (BRAND UNK)