BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMVEX FLOWMETER

    MDR report key: 11356688 · Received February 21, 2021

    Report

    Report Number
    1419185-2021-00002
    Event Type
    Death
    Date Received
    February 21, 2021
    Date of Event
    January 17, 2021
    Report Date
    February 20, 2021
    Manufacturer
    OHIO MEDICAL LLC
    Product Code
    CAX
    UDI-DI
    00628101503000
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    OHIO MEDICAL EVALUATED EXISTING FLOWMETER ASSEMBLIES IN STOCK AND NO ABNORMALITIES OR DEFECTS WERE FOUND. DUE TO THE INCONSISTENCIES IN INFORMATION PROVIDED FROM (B)(6) MEDICAL CENTER'S COMMUNICATIONS, OHIO MEDICAL WILL INVESTIGATE FURTHER.

    Description of Event or Problem · 1

    OHIO MEDICAL WAS NOTIFIED BY (B)(6) OF THE SUPPLY CHAIN OPERATIONS DEPARTMENT AT (B)(6) MEDICAL CENTER THROUGH OUR NORMAL COMPLAINT COLLECTION PROCESS ON (B)(6) 2021, OF AN ADVERSE EVENT THAT OCCURRED INVOLVING A FLOWMETER WITH POWER TAKE-OFF ADAPTER ASSEMBLY. THE BRIEF DESCRIPTION OF THE INCIDENT PROVIDED WAS "POWER TAKE-OFF WAS NOT FUNCTIONING". OHIO MEDICAL SERVICE ADMINISTRATOR (B)(4) ATTEMPTED TO CONTACT (B)(6) MEDICAL CENTER ON (B)(4) 2021, BY EMAIL FOR FURTHER INFORMATION BECAUSE THE COMPLAINT INDICATED THAT THE PRODUCT CONTRIBUTED TO DEATH, ILLNESS, OR SERIOUS INJURY, AND ALSO TO DETERMINE WHEN THE DEVICE WOULD BE RETURNED FOR EVALUATION. THESE ATTEMPTS WERE UNSUCCESSFUL AS ALL CONTACTS AT (B)(6) MEDICAL CENTER FAILED TO RESPOND. ON (B)(4) 2021, OHIO MEDICAL SR. QUALITY ASSURANCE MANAGER (B)(4) SPOKE WITH THE RISK MANAGER, (B)(6) AT (B)(6) MEDICAL CENTER AND SHE CONFIRMED THAT THE FLOWMETER ASSEMBLY DID NOT CAUSE OR CONTRIBUTE TO THE ADVERSE EVENT. THIS TELEPHONE CONVERSATION WAS SUBSEQUENTLY CONFIRMED ON (B)(4) 2021, VIA EMAIL BY (B)(6) MEDICAL CENTER RISK MANAGER (B)(6). ON FEBRUARY 10, 2021, OHIO MEDICAL RECEIVED USER FACILITY MEDWATCH REPORT (B)(4) VIA (B)(6). MEDWATCH REPORT CONTAINED A DESCRIPTION OF THE EVENT THAT WAS INCONSISTENT WITH WHAT HAD PREVIOUSLY BEEN REPORTED TO OHIO MEDICAL BY (B)(6) MEDICAL. UPON RECEIVING MEDWATCH REPORT WHOSE DETAILS CONFLICTED WITH WHAT HAD BEEN PREVIOUSLY REPORTED, OHIO MEDICAL SR. QUALITY ASSURANCE MANAGER (B)(4) CONTACTED (B)(6) MEDICAL CENTER ON FEBRUARY 11, 2021, AND FEBRUARY 16, 2021, TO CLARIFY THE INCONSISTENCY OF INFORMATION REPORTED. ON FEBRUARY 18, 2021, (B)(6) MEDICAL CENTER RISK MANAGER (B)(6) RESPONDED VIA EMAIL THAT THE USER FACILITY MEDWATCH REPORT (B)(4) WAS SUBMITTED ON JANUARY 25, 2021, WITH THE INFORMATION THAT WAS AVAILABLE AT THAT TIME. UPON DISCUSSION WITH OHIO MEDICAL ON JANUARY 27, 2021, ADDITIONAL INFORMATION HAD BEEN OBTAINED. (B)(6) MEDICAL CENTER RISK MANAGER ALSO STATED IN THE FEBRUARY 18TH EMAIL THAT THEY MIGHT SEND AN ADDENDUM TO REPORT (B)(4) TO REFLECT FACTS KNOWN AS OF JANUARY 27, 2021. OHIO MEDICAL HAS REQUESTED THE FLOWMETER WITH POWER TAKE-OFF ADAPTER ASSEMBLY BE RETURNED TO CONFIRM THAT THE DEVICE PERFORMED TO SPECIFICATION AND AS INTENDED. ON FEBRUARY 19, 2021, (B)(6) MEDICAL CENTER RISK MANAGER (B)(6) COMMUNICATED TO OHIO MEDICAL VIA EMAIL THAT THE DEVICE HAS BEEN SEQUESTERED AND WILL NOT BE RETURNED; THEREFORE, OHIO MEDICAL IS ASSESSING IF AN ON-SITE VISIT TO EVALUATE THE DEVICE IS POSSIBLE. IN THIS SAME EMAIL COMMUNICATION ON FEBRUARY 19, 2021, (B)(6) MEDICAL CENTER RISK MANAGER HAS NOW STATED THAT A COMBINATION OF THE FLOWMETER ASSEMBLY AND OXYGEN SOURCE CONTRIBUTED TO THE EVENT. FLOWMETERS ARE DEPENDENT ON A CONSISTENT AND STABLE OXYGEN SOURCE. IF THE FACILITY HAS ISSUES WITH ITS OXYGEN SOURCE OXYGEN DEPENDENT DEVICES ARE AT RISK OF FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253669 AMVEX FLOWMETER FLOWMETER CAX OHIO MEDICAL LLC FM-T-15UO T15UO20157 00628101503000

    Patients

    Seq Age Sex Outcome Treatment
    1 Death