BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDEX LOGICAL PRESSURE MONITORING SYSTEM

    MDR report key: 10209690 · Received June 29, 2020

    Report

    Report Number
    3012307300-2020-06353
    Event Type
    Death
    Date Received
    June 29, 2020
    Report Date
    September 11, 2020
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL, LTD.
    Product Code
    DRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN RECEIVED INDICATING THAT THE PROSECUTOR ADVISED THAT THEY DO NOT BELIEVE SMITHS MEDICAL HAD DONE ANYTHING WRONG. THE DEVICE IS BEING ASSESSED BY THE POLICE AND THE PROSECUTOR DOESN?T SEE ANY EVIDENCE OF CONSTRUCTIONAL FLAWS AND THAT THIS MAY CHANGE THEIR SUGGESTION THAT THERE MIGHT HAVE BEEN A MISSING SAFETY MECHANISM. IT WAS REPORTED THAT THE UNIT WILL REMAIN IN POLICE CUSTODY UNTIL THE CASE IS DONE. THE INITIAL INFORMATION ALSO ALLEGES THAT AT THIS TIME ONLY ONE DEATH OCCURRED. COMPLAINT (B)(4) HAS THE INFORMATION IN WHICH INDICATES FURTHER DETAILS ABOUT THE ALLEGED DEATH. (INFORMATION WAS RECEIVED FROM THE CUSTOMER THAT THERE WAS A CRACK AND PROBABLY TEAR NOTED OFF THE 3-WAY STOPCOCK ABOVE THE TRANSDUCER. AIR WAS REPORTED TO GET INTO THE EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SYSTEM IN WHICH THE PATIENT WAS CONNECTED. SUBSEQUENTLY, THE PATIENT SUFFERED A CARDIOVASCULAR ARREST DUE TO AN AIR EMBOLISM LEADING TO RESUSCITATION. NO SPONTANEOUS RETURN OF CIRCULATION COULD BE ACHIEVED. THE DHR WAS REVIEWED ON THE FOLLOWING: LOT NO. 3941469 (B)(4) PCS PRODUCED ON 2020-02-14) - THERE WERE NO OBSERVATIONS RECORDED DURING MANUFACTURE TO SUGGEST AN ISSUE OF THIS NATURE WOULD OCCUR WITH THIS LOT OF PRODUCT. NO SCAR, NCR AND NO DISPOSITION OF NONCONFORMING MATERIAL/PARTS WERE PROCESSED WITHIN THIS WORK ORDER CONNECTED WITH STATED ISSUE. LOT NO. 3945140 (B)(4) PCS PRODUCED ON 2020-02-21) - THERE WERE NO OBSERVATIONS RECORDED DURING MANUFACTURE TO SUGGEST AN ISSUE OF THIS NATURE WOULD OCCUR WITH THIS LOT OF PRODUCT. NO SCAR, NCR AND NO DISPOSITION OF NONCONFORMING MATERIAL/PARTS WERE PROCESSED WITHIN THIS WORK ORDER CONNECTED WITH STATED ISSUE. LOT NO. 3954724 (B)(4) PCS PRODUCED ON 2020-03-18) - THERE WERE NO OBSERVATIONS RECORDED DURING MANUFACTURE TO SUGGEST AN ISSUE OF THIS NATURE WOULD OCCUR WITH THIS LOT OF PRODUCT. NCR NO. 2361 PROCESSED WITHIN THIS WORK ORDER BUT NOT CONNECTED WITH STATED ISSUE. THE CRACKS, WHICH WERE FOUND IN 3 SEPARATE REGIONS OF THE SYSTEM, CANNOT BE CONFIRMED IF IT WAS AN ISSUE IN WHICH HAPPENED IN THE MANUFACTURING AND WAS SHIPPED TO STERILIZATION AND THEN TO DISTRIBUTION. FROM THE PROBLEM DESCRIPTION IS OBVIOUS, THAT THE PRODUCT WAS USED ON THE PATIENT. THE DAMAGE COULD HAPPEN BY MANUAL HANDLING AFTER THE PRIMING/FLUSHING OR NO PRIMING / FLUSHING WAS PERFORMED BEFORE USE.)

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT THE TRANSDUCER TO A SMITHS MEDICAL MEDEX LOGICAL PRESSURE MONITORING SYSTEM WAS FOUND TO HAVE A CRACK. DUE TO THE TEAR ABOVE THE TRANSDUCER IT WAS REPORTED TO HAVE BLOOD REFLUX FOLLOWED BY AIR IN THE SYSTEM. THE CUSTOMER FURTHER NOTED THAT THIS INCIDENT RESULTED IN DEATH. THERE WERE NO FURTHER REPORTED INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670628 MEDEX LOGICAL PRESSURE MONITORING SYSTEM TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR DRS SMITHS MEDICAL INTERNATIONAL, LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death