BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB : 8 FR - 40 CC FOS

    MDR report key: 4837992 · Received June 10, 2015

    Report

    Report Number
    1219856-2015-00123
    Event Type
    Malfunction
    Date Received
    June 10, 2015
    Date of Event
    May 21, 2015
    Report Date
    May 21, 2015
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: NO PRODUCT WAS RETURNED FOR EVALUATION. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE LOT NUMBER/SERIAL NUMBER WITH NO RELEVANT FINDINGS. THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. CONCLUSION: THE REPORTED COMPLAINT OF FOS SIGNAL LOST IS NOT ABLE TO BE CONFIRMED. NO PRODUCT WAS RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE COMPLAINT IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A PHONE CALL TO THE MANUFACTURING FACILITY. THE BIOMED CALLED THE OPERATOR. THE IAB-05840-LWS HAD BEEN CONNECTED TO THE PUMP IN THE CATH. LAB AND ZEROED PRIOR TO INSERTION. DURING THE INSERTION THE SIGNAL WAS LOST. A SECOND (IAB) INTRA-AORTIC BALLOON WAS CONNECTED TO THE PUMP. IT ZEROED SUCCESSFULLY ALSO AND DURING THE INSERTION THE SIGNAL WAS LOST. THE SECOND IAB WAS INSERTED AND THE CENTRAL LUMEN WAS UTILIZED AS THE ARTERIAL PRESSURE SIGNAL SOURCE. THE BIOMED CONNECTED THE FOS TESTER TO THE PUMP (AUTOCAT2 WAVE IABP SN: (B)(4)) AND THE PUMP WAS ABLE TO ZERO THE TESTER. THE FOS STATUS WAS OK. THE CSS ASKED IF THE BIOMED COULD GET THE FIRST IAB USED TO TEST IT. THE BIOMED CALLED BACK WHEN SHE HAD THE IAB. SHE CONNECTED IT TO THE PUMP. THE FOS ICON REMAINED BLACK AND THE FOS STATUS WAS (LL) LOW LIGHT. THE IABP FUNCTIONED APPROPRIATELY. THE ISSUE WAS WITH THE IAB. THE PATIENT OUTCOME IS LISTED AS PATIENT IS ALIVE AND RECEIVED IABP SUPPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A PHONE CALL TO THE MANUFACTURING FACILITY. THE BIOMED CALLED THE OPERATOR. THE IAB-05840-LWS HAD BEEN CONNECTED TO THE PUMP IN THE CATH. LAB AND ZEROED PRIOR TO INSERTION. DURING THE INSERTION THE SIGNAL WAS LOST. A 2ND (IAB) INTRA-AORTIC BALLOON WAS CONNECTED TO THE PUMP. IT ZEROED SUCCESSFULLY ALSO AND DURING THE INSERTION THE SIGNAL WAS LOST. THE 2ND IAB WAS INSERTED AND THE CENTRAL LUMEN WAS UTILIZED AS THE ARTERIAL PRESSURE SIGNAL SOURCE. THE BIOMED CONNECTED THE FOS TESTER TO THE PUMP (AUTOCAT2 WAVE IABP SN: (B)(4)) AND THE PUMP WAS ABLE TO ZERO THE TESTER. THE FOS STATUS WAS OK. THE CSS ASKED IF THE BIOMED COULD GET THE 1ST IAB USED TO TEST IT. THE BIOMED CALLED BACK WHEN SHE HAD THE IAB. SHE CONNECTED IT TO THE PUMP. THE FOS ICON REMAINED BLACK AND THE FOS STATUS WAS (LL) LOW LIGHT. THE IABP FUNCTIONED APPROPRIATELY. THE ISSUE WAS WITH THE IAB. THE PATIENT OUTCOME IS LISTED AS PATIENT IS ALIVE AND RECEIVING IABP SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375870 IAB : 8 FR - 40 CC FOS IAB-INTRA AORTIC BALLOON FOS SYSTEM DSP ARROW INTERNATIONAL INC. 18F14M0014

    Patients

    Seq Age Sex Outcome Treatment
    1 ANOTHER IAB CATHETER WAS USED