BEUDAMED
    FDA Adverse Event Death Summary report: N

    BODYGUARD 575 COLORVISION INFUSION PUMP

    MDR report key: 8399629 · Received March 7, 2019

    Report

    Report Number
    3006967710-2019-00002
    Event Type
    Death
    Date Received
    March 7, 2019
    Date of Event
    January 28, 2019
    Report Date
    February 5, 2019
    Manufacturer
    CME AMERICA, LLC
    Product Code
    FRN
    PMA / PMN Number
    K042696
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER DID NOT ALLEGE A DEFICIENCY WITH THE PUMP. THE CUSTOMER CALLED CME AMERICA AND REQUESTED A DOWNLOAD OF THE EVENT LOG FOR THE PUMP. EVENT LOG WAS BEING REQUESTED FOR HOSPITAL RECORDS. UPON FURTHER QUESTIONING, THE CUSTOMER STATED THE PUMP WAS PROVIDING PALLIATIVE CARE WHEN THE PATIENT DIED OF NATURAL CAUSES. THE CUSTOMER ALSO STATED THE DEVICE PERFORMED APPROPRIATELY. THEY DID NOT ALLEGE THE PUMP MALFUNCTIONED OR WAS THE CAUSE OF THE PATIENTS' DEATH. CME AMERICA REVIEWED THE EVENT LOG FOR THE DEVICE AND FOUND NO UNUSUAL FINDINGS. THE EVENT LOG SHOWED THE DEVICE RAN WITHOUT INCIDENT, THERE WERE NO ALARMS OR ALERTS IN THE EVENT LOG. DURING TESTING AND ANALYSIS OF THE DEVICE, CME AMERICA FOUND THE PUMP SHOULD BE RECALIBRATED. THERE IS AN INSIGNIFICANT RISK PER CME AMERICA'S RISK ANALYSIS ASSOCIATED WITH THE RECALIBRATION. THE DEVICE DID NOT CONTRIBUTE TO THE ADVERSE EVENT. CORRECTED DATE OF EVENT AFTER VERIFICATION FROM THE DEVICE EVENT LOG. INITIALLY THE CUSTOMER PROVIDED INFORMATION THAT THE DATE WAS (B)(6) 2019; WE CHECKED THIS INFORMATION IN THE DEVICE EVENT LOG AND CONFIRMED THE DATE WAS ACTUALLY (B)(6) 2019.

    Description of Event or Problem · 0

    THE CUSTOMER CALLED CME AMERICA AND REQUESTED A DOWNLOAD OF THE EVENT LOG FOR THE PUMP. EVENT LOG WAS BEING REQUESTED FOR HOSPITAL RECORDS. UPON FURTHER QUESTIONING, THE CUSTOMER STATED THE PUMP WAS PROVIDING PALLIATIVE CARE WHEN THE PATIENT DIED OF NATURAL CAUSES. THE CUSTOMER ALSO STATED THE DEVICE PERFORMED APPROPRIATELY. THEY DID NOT ALLEGE THE PUMP MALFUNCTIONED OR WAS THE CAUSE OF THE PATIENT'S DEATH.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION INTO THE REPORTED EVENT IS ON-GOING AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS ARE AVAILABLE. THE CUSTOMER CALLED CME AMERICA AND REQUESTED A DOWNLOAD BE PERFORMED ON THE PUMP'S EVENT LOG (HISTORY) FOR THE HOSPITAL'S RECORDS. UPON FURTHER QUESTIONING, IT WAS DETERMINED THAT THE PUMP WAS IN USE ON A PATIENT WHEN THE PATIENT DIED. THE CUSTOMER CONFIRMED THE PUMP WAS PERFORMING APPROPRIATELY AND WAS NOT ALLEGING THAT THE PUMP MALFUNCTIONED, IT WAS NOT A CAUSE OF THE DEATH. CME AMERICA WILL PROVIDE THE EVENT LOG TO THE CUSTOMER AND CONDUCT AN INVESTIGATION ON THE DEVICE AS PER OUR PROCEDURES.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED CME AMERICA AND REQUESTED A DOWNLOAD BE PERFORMED ON THE PUMP'S EVENT LOG (HISTORY) FOR THE HOSPITAL'S RECORDS. UPON FURTHER QUESTIONING, IT WAS DETERMINED THAT THE PUMP WAS IN USE ON A PATIENT WHEN THE PATIENT DIED. THE CUSTOMER CONFIRMED THE PUMP WAS PERFORMING APPROPRIATELY AND WAS NOT ALLEGING THAT THE PUMP MALFUNCTIONED, IT WAS NOT A CAUSE OF THE DEATH. CME AMERICA WILL PROVIDE THE EVENT LOG TO THE CUSTOMER AND CONDUCT AN INVESTIGATION ON THE DEVICE AS PER OUR PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193800 BODYGUARD 575 COLORVISION INFUSION PUMP BG 575 CV PUMP FRN CME AMERICA, LLC 100-620XCV

    Patients

    Seq Age Sex Outcome Treatment
    1 Death