BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB : 8 FR - 40 CC FOS

    MDR report key: 2481132 · Received March 2, 2012

    Report

    Report Number
    1219856-2012-00082
    Event Type
    Malfunction
    Date Received
    March 2, 2012
    Date of Event
    February 17, 2012
    Report Date
    March 2, 2012
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 VIA A CALL FROM THE RN TO THE CLINICAL SUPPORT SPECIALIST (CSS) AT 0855 MST THAT A DAMPENED AP (ARTERIAL PRESSURE) FROM THE XDUCER AND THE FOS WASN'T WORKING. THE IAB WAS INSERTED THROUGH THE SHEATH VIA FEMORAL WITH NO ISSUES AND INDWELLING FOR APPROXIMATELY 16 HOURS. THE CSS ASKED THE RN WHAT COLOR THE LIGHT BULB ICON IS AND THE RN STATED IT WAS BLACK WITH A BLUE BACKGROUND. THE RN SAID THAT IT WAS BLUE BEFORE, BUT THEY HAD DISCONNECTED TO UNTANGLE SOME LINES AND WHEN THE PUMP WAS RECONNECTED IT WOULDN'T RECOGNIZE THE FOS (FIBEROPTIX SENSOR). IT WAS ATTEMPTED TO RECONNECT THE FOS AND THE CAL KEY WITHOUT ANY CHANGE. THE CSS ASKED IF THE TIP ON THE FOS CONNECTOR APPEARED TO BE RECESSED AND THE RN STATED THAT IT DID NOT APPEAR SO. THE PUMP IS UTILIZING THE XDUCER IN AUTOPILOT. THE RN STATED THAT THE WAVEFORM IS DAMPENED. THE CSS HAD THE RN FLUSH THE CENTRAL LUMEN WITH THE PUMP ON STANDBY. THE RN SAID THAT IT WAS VERY SLUGGISH TO FLUSH AND THE WAVEFORM DID NOT IMPROVE. THE CSS TOLD THE RN THAT WOULD INDICATE A CLOTTED CENTRAL LUMEN. THERE IS A RADIAL AP AVAILABLE AND THE CSS HAD THE RN CONNECT THAT TO THE PUMP DIRECTLY. THE RN STATED THAT THE WAVEFORM IS MUCH BETTER NOW. PRESSURES ARE SYSTOLE 67/70. AUGMENTATION 109, DIASTOLE 11/25. THE CSS EXPLAINED AUGMENTATION AND AFTER LOAD REDUCTION TO THE RN AND THAT IT APPEARS TO BE ACHIEVING THE GOALS OF THERAPY. THE RN THANKED THE CSS FOR THE HELP. THE CSS LEFT THE DIRECT NUMBER SHOULD THEY NEED ANY FURTHER ASSISTANCE. AT 1210 MST THE CSS RECEIVED A CALL FROM THE SALES REPRESENTATIVE (SR). THE SR HAD BEEN IN TO SEE THE STAFF AND THEY STATED THAT THE PRESSURES ON THE PUMP DID NOT MATCH PRESSURES ON THE MONITOR. THEY STATED THAT THEY HAD ZEROED THE AP ON THE PUMP. THE SR HAD THEM DO IT AGAIN WHILE WATCHING AND THE SR NOTICED THEY HAD NOT BEEN ZEROING IT PROPERLY. AFTER THE LINE WAS ZEROED, PRESSURES NOW MATCHED UP PERFECTLY WITH THOSE ON THE MONITOR. THE CSS THANKED THE SR FOR STOPPING BY. THE ISSUE WAS RESOLVED BY CONNECTING RADIAL AP TO THE PUMP. THERE WAS NO REPORT OF PATIENT DEATH, COMPLICATIONS OR INJURY. NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. NO DELAY OR INTERRUPTION IN THERAPY. THE PATIENT OUTCOME IS STABLE. IT WAS NOTED THAT THE INTRA-AORTIC BALLOON PUMP USED WAS THE IAP-0500.

    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 INTL., INC. NA

    Patients

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