BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB : 8 FR - 40 CC FOS

    MDR report key: 4132994 · Received September 29, 2014

    Report

    Report Number
    1219856-2014-00182
    Event Type
    Malfunction
    Date Received
    September 29, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 4, 2014
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RCIS IN THE CATH LAB CALLED TO TROUBLESHOOT "HE LOSS 2 ALARMS" ON THE INTRA-AORTIC BALLOON PUMP (S/N (B)(4)). THE RCIS STATED THE TANK WAS FINE AND THERE WAS NO BLOOD NOTED IN THE TUBING. THEY HAD ALREADY SWITCHED OUT THE MACHINE (FIRST MACHINE SN (B)(4)) AND THEY WERE STILL HAVING ALARMS. THEY HAD DECREASED THE VOLUME IN THE IAB (40CC) DOWN TO 30CC WITH NO CHANGE IN ALARMS. THE PT IS (B)(6) AND THEY ARE NOT SURE WHY THEY PUT IN A 40CC. THERE WAS NO BLOOD IN THE TUBING. THE CSS DISCUSSED WITH THE RCIS AND CHARGE RN HOW TO DETERMINE THE RIGHT VOLUME IN THE INTRA-AORTIC BALLOON (IAB) TO FIT THE AORTA AND THAT THIS DID NOT CHANGE THE FACT THAT THEY MAY STILL HAVE RENAL ARTERY OCCLUSION PROBLEMS DUE TO THE LENGTH OF THE 40CC MEMBRANE. THE CHARGE RN SENT THE CSS A STRIP. THE CHARGE RN STATED HE HAD TRIED OPERATOR MODE AND MULTIPLE TRIGGERS WITH NO IMPROVEMENT. HE ALSO STATED THE PATIENT HAD ENDOVASCULAR STENTING ON BOTH SIDES AND WONDERED IF THAT COULD HAVE CAUSED THE ABRASION DURING INSERTION. THE CSS AGREED THAT IT WAS POSSIBLE. AFTER LENGTHY DISCUSSION, THE CHARGE RN STATED THAT THERE WAS NO KINK EXTERNALLY OR VISIBLE. THE CSS DISCUSSED THAT THE BPW (BALLOON PRESSURE WAVEFORM) DID SHOW SOME DEGREE OF KINKING, WHICH COULD INDICATED THAT THIS WAS A POSSIBLE LEAK IN THE IAB. THE CHARGE RN STATED THAT WAS WHAT HE HAD BEEN TRYING TO TELL THEM. THE CSS DISCUSSED A LEAK TEST WITH THE CHARGE RN. THE CSS EXPLAINED THAT WILL ONLY PROVE THE ISSUE IF INSIDE THE CATHETER OR EXTERNAL TO THE PUMP. THE CSS STATED IT COULD BE KINK AND/OR LEAK RELATED AND EITHER WAS IF THE CATHETER FAILED THE RECOMMENDATION IS REMOVAL. THE CHARGE RN UNDERSTOOD AND AGREED. THE CHARGE RN STATED THEY WERE ONLY USING IT FOR INTERVENTION AND WERE GOING TO REMOVE IT RIGHT AFTER. HE DISCUSSED THIS WITH THE DOCTOR AND THE IAB WILL BE REMOVED, BUT NOT REPLACED. THE CHARGE RN STATED THAT THE PT WAS DOING FINE. THERE ARE NO COMPLICATIONS NOTED TO THE IAB. ADDITIONAL INFO RECEIVED STATED THAT THE MD KEPT THE SHEATH IN THE PATIENT BECAUSE IT WAS "THE BEST WAY FOR THEM TO RETAIN ACCESS AND MEANT THEY DIDN'T HAVE TO UPSIZE ON SHEATH. THIS PT HAD BIG ISSUES WITH LOSS OF PULSE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606726 IAB : 8 FR - 40 CC FOS INTRA-AORTIC BALLOON FIBEROPTIC SYST DSP ARROW INTL., INC.

    Patients

    Seq Age Sex Outcome Treatment
    1