BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8F FR - 40 CC FOS

    MDR report key: 3180131 · Received June 13, 2013

    Report

    Report Number
    1219856-2013-00139
    Event Type
    Malfunction
    Date Received
    June 13, 2013
    Date of Event
    May 24, 2013
    Report Date
    June 11, 2013
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENT INVOLVED A MALE PATIENT WHILE IN THE CARDIAC CATH LAB DURING USE. THE DOCTOR INSERTED THE INTRA-AORTIC BALLOON (IAB) THROUGH THE SHEATH VIA RIGHT SIDE OF THE PATIENT WITH NO ISSUES. IMMEDIATELY AFTER INSERTION, THE PUMP ALARMED "GAS LEAK." NO BLOOD WAS OBSERVED IN THE DRIVELINE. THE RN STATED THAT THE DRIVELINE DID NOT APPEAR TO BE COMPLETELY CONNECTED TO THE IAB. THE RN HAD TO PUSH AND ADVANCE THE TUBING TO COMPLETE THE CONNECTION. THE RN BELIEVES THAT THIS IS WHAT CAUSED THE GAS LEAK. THEY IMMEDIATELY REMOVED THE IAB. THERE WAS NOT ANOTHER ATTEMPT TO INSERT ANOTHER IAB BECAUSE THE DOCTOR DECIDED THE PATIENT DID NOT NEED INTRA-AORTIC BALLOON PUMP (IABP) THERAPY. THERE WAS NO REPORT OF PATIENT DEATH, COMPLICATIONS OR INJURY. NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. THE THERAPY WAS INTERRUPTED INDEFINITELY. THERE WERE NO PUMP STRIPS GENERATED AND NO X-RAYS PERFORMED. THE PATIENT OUTCOME IS THE PATIENT IS STILL ADMITTED. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013 REPORTED THAT THE RN CLAIMED THAT HE PUSHED THE TUBING ON FURTHER BECAUSE IT FELT LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269819 IAB: 8F FR - 40 CC FOS INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM (FOS) DSP ARROW INTL., INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN INTRA-AORTIC BALLOON PUMP