BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB : 8 FR - 30 CC FOS

    MDR report key: 2043143 · Received February 24, 2011

    Report

    Report Number
    1219856-2011-00076
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 17, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    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 HAS BEEN REPORTED VIA A CALL REPORT THAT THE INTRA-AORTIC BALLOON PUMP (IABP) WAS ALARMING POSSIBLE HELIUM LOSS 2. PER THE RN THE ALARM HAS BEEN OCCURRING EVERY COUPLE MINUTES SINCE INSERTION. THE PATIENT (PT.) IS NOT EXPERIENCING SIGNIFICANT ECTOPY, CONNECTIONS HAVE BEEN TIGHTENED AND THERE ARE NO VISIBLE KINKS OR BLOOD IN THE DRIVELINE TUBING. THE CONSOLE WAS EXCHANGED AND THE HELIUM LOSS ALARM 2 CONTINUED. THE PT IS OF NORMAL BMI (BODY MASS INDEX), ANGLE OF INSERTION IS NORMAL AND THE PT IS LAYING AT 0 DEGREES HOB (HEAD OF BED) AND NOT MOVING LIMB. THE RN ALSO REPORTED THAT THE PT DID NOT HAVE A TORTUOUS ANATOMY. AS THE CLINICAL SUPPORT SPECIALIST (CSS) WAS SPEAKING TO THE RN, THE ALARM SOUNDED TWICE (LESS THAN 2 MIN). THE CSS RELAYED THAT ALTHOUGH SHE IS NOT SEEING ANY BLOOD IN THE INTRA-AORTIC BALLOON (IAB) TUBING, IT WAS A PROBABLE RUPTURE. THE CSS SUGGESTED THAT THEY EXCHANGE THE IAB FOR ANOTHER AND SAVE THE AFFECTED CATHETER FOR RETRIEVAL. PER THE CHIEF PERFUSIONIST THE IAB WAS REMOVED AND REPLACED WITHOUT INCIDENT. THE SECOND IAB WAS INSERTED IN THE SAME INSERTION SITE. AFTER INSERTION, THE PT WAS TRANSFERRED FROM THE CARDIAC CATH LAB TO THE INTENSIVE CARE UNIT. DETAILS OF THE EVENT: THE PT WAS LATER TRANSFERRED TO A SISTER HOSPITAL. PER THE TRANSPORT RN, "WHILE GOING OVER THE MOUNTAIN HE RECEIVED ONE HELIUM LOSS ALARM." THE RN ON THE TRANSPORT TEAM CALLED THE CSS AND RELAYED THE DESCRIPTION OF THE TRIP OVER THE MOUNTAIN AND THE HELIUM LOSS ALARM TO THE CSS. THE RN WAS INQUIRING AS TO "HOW TO START THE PUMP AGAIN." THE CSS COULD HEAR THE PUMP ALARMING; THE RN CONFIRMED THAT THE PT WAS STABLE WITHOUT THE PUMP PUMPING. THE CSS TOLD THE RN TO PRESS THE "RESET BUTTON" AND THE "GO BUTTON." THE PUMP BEGAN PUMPING WITHOUT DIFFICULTY. THE CSS EXPLAINED TO THE RN WHAT THE HELIUM LOSS ALARM MEANT. THE CSS ALSO TOLD THE RN THAT THE ALARM COULD HAVE BEEN CAUSED BY KINKING WITH THE MOVEMENT OF THE AMBULANCE. AT THIS TIME THE RN STATED THAT "THEY HAD JUST ARRIVED AT THE FACILITY AND NEEDED TO GET THE PATIENT INSIDE." PER THE CSS SHE WAS UNABLE TO CONFIRM IF THE DRIVELINE TUBING WAS CLEAR OF ANY BLOOD OR GET THE SERIAL NUMBER FOR THE CATHETER. THE ALARM ONLY OCCURRED ONCE. ADDITIONAL INFORMATION RECEIVED FROM THE RN ON (B)(6) 2011 STATED "THE PERSON THAT I SPOKE WITH ON THE PHONE DURING TRANSPORT WAS VERY HELPFUL. THERE WAS NO BLOOD IN THE TUBING AND THE PT ARRIVED SAFE AT THE ACCEPTING FACILITY. THERE WAS NO HARM OR NEGATIVE OUTCOME, THE PT REMAINED ASYMPTOMATIC THROUGHOUT THE ENTIRE TRANSFER. THE SAME TUBING AND LINES WERE USED WHEN THE PT WAS TRANSFERRED FROM OUR IABP TO THE NEW FACILITIES IABP." REFERENCE MDR # 1219856-2011-00077 FOR THE RELATED IABP REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB : 8 FR - 30 CC FOS INTRA-AORTIC BALLOON FIBER OPTIC SYSETM (FOS) DSP ARROW INTL., INC. NA

    Patients

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