BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FASTRESPONDER STERNAL INTRAOSSEOUS DEVICE

    MDR report key: 4878829 · Received June 30, 2015

    Report

    Report Number
    0009615387-2015-00003
    Event Type
    Malfunction
    Date Received
    June 30, 2015
    Date of Event
    January 28, 2015
    Report Date
    June 30, 2015
    Manufacturer
    PYNG MEDICAL CORPORATION
    Product Code
    FMI
    PMA / PMN Number
    K130487
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PYNG MEDICAL BELIEVES THAT THE ADDITIONAL TRAINING MATERIALS PRODUCED ALONG WITH THE REQUIREMENT THAT NEW, FIRST TIME USERS CORROBORATE THAT THEY HAVE RECEIVED AND UNDERSTOOD THE TRAINING MATERIALS WILL REDUCE THE FREQUENCY OF INSERTION FAILURES FOR FIRST TIME USERS. WITH REGARD TO THE DEVICE "COMING APART", THE LIKELIHOOD OF A RE-OCCURRENCE OF THIS REPORTED PRODUCT DEFECT IS EXTREMELY REMOTE, ESPECIALLY NOW THAT THE MANUFACTURER HAS BEEN MADE AWARE OF THIS POTENTIAL. (B)(4). PYNG MEDICAL IS FILING THIS REPORT AS A CONSERVATIVE INTERPRETATION OF THE FDA REGULATIONS, IN THE ABUNDANCE OF CAUTION, AND AS A MORE STRICT INTERPRETATION OF INTERNAL SOPS REGARDING THE FILING OF EVENTS OCCURRING OUTSIDE OF THE US.

    Description of Event or Problem · 1

    TIMELINE OF EVENTS IN 2015: (B)(6): PYNG MEDICAL RECEIVED AN INITIAL REPORT THROUGH A DISTRIBUTOR REGARDING THE INCIDENT. THE REPORT WAS VAGUE IN THAT THE FASTR DEVICE "FELL APART" AND THE ER PHYSICIAN USED ANOTHER ONE (NO INDICATION AT THAT TIME THAT IT WAS NOT SUCCESSFUL). BOTH DEVICES WERE DISCARDED. FEB 2 AND 12: PYNG MEDICAL FOLLOWED UP TWICE WITH THE ER PHYSICIAN BUT RECEIVED NO RESPONSE UNTIL FEB 28. FEB 28: ADDITIONAL DETAILS RECEIVED FROM ER PHYSICIAN. HE DESCRIBED MORE FULLY HOW THE FIRST DEVICE "FELL APART" AND ALSO SAID THE SECOND ATTEMPT WAS NOT TOTALLY SUCCESSFUL IN THAT FLUIDS THAT THEY WERE TRYING TO ADMINISTER CAME OUT AROUND THE INFUSION TUBE (INFILTRATION). HE ADMITTED TO HIS OWN USE ERROR AND ALSO THAT THE PATIENT WAS UNDER CARDIAC ARREST. MAR 05: PYNG MEDICAL FOLLOWED UP AGAIN VIA EMAIL INCLUDING DEVICE DIAGRAMS TO GET A BETTER IDEA OF THE MALFUNCTION AND ALSO TO DETERMINE THE PATIENT OUTCOME. MAR 19: ER PHYSICIAN RESPONDED VIA EMAIL AND USING THE DIAGRAM PROVIDED TO POINT OUT THE PARTS THAT "FELL APART" AND PROVIDED MORE INFORMATION ABOUT THE OVERALL INCIDENT AND ALSO THAT THE PATIENT DIED. MAR 23: PYNG MEDICAL ASKED THE ER PHYSICIAN SPECIFICALLY IF, IN HIS PROFESSIONAL OPINION, THE PATIENT DEATH WAS CAUSED BY THE FAILURE OF THE FASTR DEVICE. MAR 23: THE ER PHYSICIAN INDICATED THAT THE PATIENT'S DEATH WAS NOT RELATED TO THE USE OF THE FASTR DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421466 FASTRESPONDER STERNAL INTRAOSSEOUS DEVICE FASTR FMI PYNG MEDICAL CORPORATION FASTR 87414313

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other