BEUDAMED
    FDA Adverse Event Death Summary report: N

    FIBEROPTIX ULTRA 8 IAB: 8FR 40CC

    MDR report key: 11749220 · Received April 29, 2021

    Report

    Report Number
    3010532612-2021-00106
    Event Type
    Death
    Date Received
    April 29, 2021
    Date of Event
    March 19, 2021
    Report Date
    March 30, 2021
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DSP
    UDI-DI
    00801902007247
    PMA / PMN Number
    K021462
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    QN# (B)(4). THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. THE REPORTED COMPLAINT OF IAB: BLOOD IN HELIUM PATHWAY IS NOT ABLE TO BE CONFIRMED. THE CUSTOMER PHOTO WAS REVIEWED, HOWEVER; THE COMPLAINT COULD NOT BE CONFIRMED BASED ON THE PUMP ALARM LOG FILE. ADDITIONALLY, IT WAS NOTED FROM THE CUSTOMER PHOTO THAT PUMPING WAS INITIATED BY THE USER AFTER NOTICING BLOOD IN THE DRIVELINE TUBING. IN THE EVENT OF A SUSPECTED BALLOON PERFORATION, THE IFU STATES: "IMMEDIATELY STOP PUMPING. CONSIDER TAPERING OR DISCONTINUING ANTICOAGULATION THERAPY." AND "REMOVE IAB FROM PATIENT, USING RECOMMENDED REMOVAL TECHNIQUE." AN IN-SERVICE WAS REQUESTED TO REITERATE THE INSTRUCTIONS FOR USE (IFU) TO THE CUSTOMER. THE ROOT CAUSE OF THE COMPLAINT IS UNDETERMINED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE LOT NUMBER WITH NO RELEVANT FINDINGS. THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. TELEFLEX ASSESSED THE RISK FOR THE REPORTED COMPLAINT. THERE ARE NO NEW OR REVISED RISK. THIS WILL BE MONITORED FOR ANY DEVELOPING TRENDS. OTHER REMARKS: ON 29 APR 2021 AN EXPEDITED IN-SERVICE WAS REQUESTED FOR UPMC PRESBYTERIAN HOSPITAL TO REVIEW HE LOSS ALARM TROUBLESHOOTING AND ACTIONS AFTER A SUSPECTED BALLOON PERFORATION DUE TO THE INCREASED PATIENT RISK BASED ON THE ALARM LOG FILE AND EVENT DETAILS. IT WAS NOTED IN THE COMPLAINT THAT BLOOD WAS SEEN IN THE HELIUM DRIVELINE TUBING AT 10:40 PM AND THE IABC WAS REMOVED AT 11:00 PM. IN BETWEEN THOSE TIMES THERE WERE 15 HIGH PRIORITY ALARMS ISSUED, INCLUDING HE LOSS 3 ALARMS. HIGH PRIORITY ALARMS WILL IMMEDIATELY STOP PUMPING AS A SAFETY FEATURE. IN ORDER FOR ANOTHER HIGH PRIORITY ALARM TO BE ISSUED AFTER THAT, PUMPING MUST BE INITIATED AGAIN BY THE USER. THE FINAL ALARM IN THE LOG FILE WAS ISSUED AT 10:58 PM, INDICATING THE CORRECT TIMES ARE LISTED IN THE FILE. THIS GOES AGAINST THE TELEFLEX IABP OPERATION MANUAL. FROM THE HE LOSS ALARM TROUBLESHOOTING SECTION, "IT IS IMPERATIVE THAT THE FIRST ACTION IS TO CHECK FOR THE PRESENCE OF BLOOD IN THE DRIVELINE TUBING. IF BLOOD IS PRESENT, DO NOT RESUME PUMPING. CONTACT THE PHYSICIAN AND PREPARE FOR IAB REMOVAL." IN THE FLOWCHART LOCATED IN THIS SECTION, IF BLOOD IS FOUND, "STOP PUMPING, REMOVE IAB AS SOON AS POSSIBLE AND REPLACE AS NECESSARY, AND CLAMP IAB TUBING." IAB IFU WARNINGS IF YOU SUSPECT BALLOON PERFORATION: IMMEDIATELY STOP PUMPING. CONSIDER TAPERING OR DISCONTINUING ANTICOAGULATION THERAPY. REMOVE IAB FROM PATIENT, USING RECOMMENDED REMOVAL TECHNIQUE. THESE STEPS ARE IMPERATIVE TO ENSURE PATIENT SAFETY AS NOT PROPERLY FOLLOWING THE RECOMMENDED ACTIONS CAN RESULT IN SERIOUS INJURY TO THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INTRA-AORTIC BALLOON (IAB) WAS INSERTED INTO THE PATIENT VIA LEFT FEMORAL. IT WAS NOTED BY THE STAFF THAT BLOOD HAD ENTERED THE IAB DRIVELINE AT 10:40PM. AS A RESULT, THE IAB WAS REMOVED AT 11:00PM BY (B)(6), AND THERE WAS NO ISSUE DURING REMOVAL. ONE HOUR AFTER REMOVAL THE PATIENT WAS UNRESPONSIVE, NOT MOVING LOWER EXTREMITIES. STROKE SYMPTOMS WERE NOTED. PUPILS NON-REACTIVE AT 0300. CT SCAN WITHOUT CONTRAST AT 0600 AND FRONTAL LOBAL INFARCTION NOTED (THROMBUS). THERE WAS A REPORT OF PATIENT DEATH. TELEFLEX MADE MULTIPLE ATTEMPTS TO CONTACT THE HOSPITAL TO DETERMINE IF THE DEVICE CAUSED OR CONTRIBUTED TO PATIENT DEATH. DESPITE OUR BEST EFFORTS, NO ADDITIONAL INFORMATION COULD BE OBTAINED.

    Additional Manufacturer Narrative · 1

    QN#(B)(4). OTHER REMARKS: ON 29 APR 2021 AN EXPEDITED IN-SERVICE WAS REQUESTED FOR (B)(6) HOSPITAL TO REVIEW HE LOSS ALARM TROUBLESHOOTING AND ACTIONS AFTER A SUSPECTED BALLOON PERFORATION DUE TO THE INCREASED PATIENT RISK BASED ON THE ALARM LOG FILE AND EVENT DETAILS. IT WAS NOTED IN THE COMPLAINT THAT BLOOD WAS SEEN IN THE HELIUM DRIVELINE TUBING AT 10:40 PM AND THE IABC WAS REMOVED AT 11:00 PM. IN BETWEEN THOSE TIMES THERE WERE 15 HIGH PRIORITY ALARMS ISSUED, INCLUDING HE LOSS 3 ALARMS. HIGH PRIORITY ALARMS WILL IMMEDIATELY STOP PUMPING AS A SAFETY FEATURE. IN ORDER FOR ANOTHER HIGH PRIORITY ALARM TO BE ISSUED AFTER THAT, PUMPING MUST BE INITIATED AGAIN BY THE USER. THE FINAL ALARM IN THE LOG FILE WAS ISSUED AT 10:58 PM, INDICATING THE CORRECT TIMES ARE LISTED IN THE FILE. THIS GOES AGAINST THE TELEFLEX IABP OPERATION MANUAL. FROM THE HE LOSS ALARM TROUBLESHOOTING SECTION, "IT IS IMPERATIVE THAT THE FIRST ACTION IS TO CHECK FOR THE PRESENCE OF BLOOD IN THE DRIVELINE TUBING. IF BLOOD IS PRESENT, DO NOT RESUME PUMPING. CONTACT THE PHYSICIAN AND PREPARE FOR IAB REMOVAL." IN THE FLOWCHART LOCATED IN THIS SECTION, IF BLOOD IS FOUND, "STOP PUMPING, REMOVE IAB AS SOON AS POSSIBLE AND REPLACE AS NECESSARY, AND CLAMP IAB TUBING." IAB IFU WARNINGS: IF YOU SUSPECT BALLOON PERFORATION: IMMEDIATELY STOP PUMPING. CONSIDER TAPERING OR DISCONTINUING ANTICOAGULATION THERAPY. REMOVE IAB FROM PATIENT, USING RECOMMENDED REMOVAL TECHNIQUE. THESE STEPS ARE IMPERATIVE TO ENSURE PATIENT SAFETY AS NOT PROPERLY FOLLOWING THE RECOMMENDED ACTIONS CAN RESULT IN SERIOUS INJURY TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTRA-AORTIC BALLOON (IAB) WAS INSERTED INTO THE PATIENT VIA LEFT FEMORAL. IT WAS NOTED BY THE STAFF THAT BLOOD HAD ENTERED THE IAB DRIVELINE AT 10:40PM. AS A RESULT, THE IAB WAS REMOVED AT 11:00PM BY DR. MURRAY, AND THERE WAS NO ISSUE DURING REMOVAL. ONE HOUR AFTER REMOVAL THE PATIENT WAS UNRESPONSIVE, NOT MOVING LOWER EXTREMITIES. STROKE SYMPTOMS WERE NOTED. PUPILS NON-REACTIVE AT 0300. CT SCAN WITHOUT CONTRAST AT 0600 AND FRONTAL LOBAL INFARCTION NOTED (THROMBUS). THERE WAS A REPORT OF PATIENT DEATH. TELEFLEX MADE MULTIPLE ATTEMPTS TO CONTACT THE HOSPITAL TO DETERMINE IF THE DEVICE CAUSED OR CONTRIBUTED TO PATIENT DEATH. DESPITE OUR BEST EFFORTS, NO ADDITIONAL INFORMATION COULD BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639582 FIBEROPTIX ULTRA 8 IAB: 8FR 40CC SYSTEM, BALLOON, INTRA-AORTIC DSP ARROW INTERNATIONAL INC. IPN000254 18F20K0019 00801902007247

    Patients

    Seq Age Sex Outcome Treatment
    1 Death