BEUDAMED
    FDA Adverse Event Death Summary report: N

    PALL SMALL VOLUME HEAT & MOISTURE EXCHANGER

    MDR report key: 109914 · Received August 4, 1997

    Report

    Report Number
    9680602-1997-00001
    Event Type
    Death
    Date Received
    August 4, 1997
    Date of Event
    July 10, 1997
    Report Date
    July 11, 1997
    Manufacturer
    PALL NEWQUAY, LTD.
    Product Code
    BYD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION/ANALYSIS THE RETURNED DEVICE WAS FOUND TO BE REPRESENTATIVE OF CURRENT MFG PRODUCT AND EXHIBITED NORMAL FLOW/PRESSURE CHARACTERISTICS WHEN TESTED. THIS IS IN AGREEMENT WITH THE OBSERVATION OF THE ICU CHIEF, WHO TESTED THE DEVICE WITH A RESERVOIR BAG 10-12 HOURS AFTER THE INVESTIGATION. IN THE FIRM'S OPINION, THE RETURNED DEVICE HAD NOT MALFUNCTIONED IN ANY WAY AND DID NOT CONTRIBUTE TO THE PT'S DEATH. FURTHERMORE, THE MEDICAL EXAMINER, HAS VERBALLY INFORMED REPRESENTATIVES OF THE FIRM THAT THE PT HAD MYOCARDIAL INFARCTION OF THE WALL OF THE LEFT VENTRICLE AND THAT THE DEVICE DID NOT CONTRIBUTE TO THE PT'S DEATH. ADDITIONL INFO: CO HAS WRETTEN TO THE PATHOLOGIST FOR ADDITIONAL INFO AND TO CONFIRM CO'S STATEMENT, BUT HAVE NOT RECEIVED A RESPONSE. UNLESS SUBSTANTIALLY SIGNIFICANT INFO BECOMES AVAILABLE, THIS CONSTITUTES A FINAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT WITH COPD WAS ADMITTED TO THE HOSPITAL'S EMERGENCY DEPT DUE TO HYPONATRAEMIA AND LOSS OF CONSCIOUSNESS. THE PT WAS CONNECTED TO A IMV-BIRD VENTILATOR. A PALL BB25 DEVICE WAS PRESENT AT THE PT END. VENTOLIN AND ATROVENT WERE NEBULIZED TO THE PT. TEN (10) MINUTES AFTER NEBULIZATION IT WAS NOTICED THAT THE PT WAS CYANOTIC. ATTENTION WAS DRAWN TO THE FACT THAT THE PT'S CHEST WAS NOT MOVING IN RESPONSE TO THE VENTILATOR. ATTEMPTS TO RESUSCIATE THE PT WERE UNSUCCESSFUL. THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALL SMALL VOLUME HEAT & MOISTURE EXCHANGER SMALL VOLUME HEAT & MOISTURE EXCHANGER BYD PALL NEWQUAY, LTD. BB25 701501

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death