BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 40 CC FOS

    MDR report key: 2080105 · Received April 7, 2011

    Report

    Report Number
    1219856-2011-00119
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Date of Event
    March 29, 2011
    Report Date
    April 4, 2011
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    REFERENCE MDR # 1219856-2011-00118 FOR THE PUMP EVENT INVOLVING THE SAME PT. IT WAS REPORTED THAT THE EVENT OCCURRED IN THE CATH LAB. PRIOR TO INSERTION, THE FIBEROPTIX SENSOR (FOS) AND CAL KEY WERE CONNECTED TO THE PUMP AND THE PUMP DETECTED THE SLIDE AND KEY; AUTOMATIC ZEROING WAS COMPLETED. THE INTRA-AORTIC BALLOON (IAB) WAS INSERTED SUCCESSFULLY USING A SHEATH VIA THE PTS' LEFT FEMORAL ARTERY. AFTER THE INTRA-AORTIC BALLOON PUMP (IABP) THERAPY BEGAN, THE PUMP ALARMED "HELIUM LOSS" EVERY TWO MINUTES. WHILE UNDER X-RAY, THE POSITION OF THE IAB CATHETER WAS CORRECTED. IT WAS AT THAT TIME THE FOS FADED OUT AND MANUAL ZEROING COULD NOT BE DONE. IT WAS NOTED THAT THE CATHETER WAS NOT KINKED, BLOOD WAS NOT VISIBLE IN THE LINE AND THE HELIUM LINE WAS CONNECTED CORRECTLY. AS A RESULT, THE IAB WAS REMOVED AND A DATASCOPE IAB WAS INSERTED. THERE WAS NO REPORTED PT DEATH OR INJURY. MEDICAL/SURGICAL INTERVENTION WAS NOT REQUIRED. THERE WAS A DELAY IN IABP THERAPY UNTIL AFTER THE SECOND IAB COULD BE INSERTED. THERE WERE NO REPORTED PT COMPLICATIONS. THE PT OUTCOME IS LISTED AS OK. ADD'L INFO RECEIVED ON (B)(4) 2011 FROM THE CLINICAL SUPPORT SALES REP STATED THAT DRY OLD BLOOD WAS FOUND IN THE CONDENSATION CONTAINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB: 8 FR - 40 CC FOS INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM (FOS) DSP ARROW INTERNATIONAL INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK DATASCOPE INTRA-AORTIC BALLOON