BEUDAMED
    FDA Adverse Event Death Summary report: N

    SMARTEZ ELASTOMERIC PUMP

    MDR report key: 16529218 · Received March 13, 2023

    Report

    Report Number
    3012429465-2023-00001
    Event Type
    Death
    Date Received
    March 13, 2023
    Date of Event
    January 13, 2023
    Report Date
    February 28, 2023
    Manufacturer
    EPIC INTERNATIONAL (THAILAND) CO., LTD.
    Product Code
    MEB
    PMA / PMN Number
    K151650
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER: EPIC INTERNATIONAL THAILAND CO., LTD. PRODUCT: SMARTEZ ELASTOMERIC PUMP; MODEL#: 484041; LOT#: C22E043. ADVERSE EVENT REPORTED: A 64-YEAR-OLD MALE WAS PRESENTED TO EMERGENCY DEPARTMENT WITH COMPLAINTS OF CHEST ABDOMINAL PAIN STATUS POST SYNCOPAL EPISODE & EXPIRED. ON FEBRUARY 1, 2023, WE RECEIVED A MEDWATCH (MW5114504) REPORT OF AN ADVERSE EVENT REPORTED BY USER FACILITY WHO HAD USED OUR SMARTEZ ELASTOMERIC PUMP. AS PER THE DESCRIPTION OF THE REPORT, 64-YEAR-OLD MALE PATIENT (IDENTIFIER: (B)(6), WEIGHT:62KG) WAS PRESENTED TO CANCER CENTRE FOR CONTINUOUS INFUSION OF 5FU (FLUOROURACIL) BY ELASTOMERIC PUMP. PATIENT RETURNED FOR DISCONNECT & REPORTED THAT INFUSION COMPLETED IN 5HRS. PATIENT WAS PRESENTED TO EMERGENCY DEPARTMENT WITH COMPLAINTS OF CHEST ABDOMINAL PAIN STATUS POST SYNCOPAL EPISODE & EXPIRED. PATIENT HAD BEEN ON FOLFIRI SINCE (B)(6) 2022. LAST DOSE WAS PLACED ON CONTINUOUS INFUSION ON (B)(6) 2023 AT APPROXIMATELY 8:30AM. IT WAS A 46-HOUR INFUSION AND PATIENT RETURNED FOR DISCONNECT ON (B)(6) 2023. PUMP WAS DISCONNECTED AT APPROXIMATELY 12:30PM. PATIENT DIED ON (B)(6) 2023. THE PATIENT HAD PRE-EXISTING CONDITIONS OF LIVER MASS WITH LIVER RESECTION, METASTATIC CA - LIVER AND LUNG, +SMOKER, COLOSTOMY, NEUROPATHY, GERD AS PER THE INFORMATION PROVIDED BY (B)(6) HOSPITAL, CONTACT (B)(6), HEALTH PROFESSIONAL. THE LABORATORY TEST DATA INDICATES WBC 2.1, BUN 65, BILIRUBIN 1.6, ALP - 251, PT 16, HGB 13.7, HCT - 40 & THE DIAGNOSIS REPORT SHOWS MULTISYSTEM ORGAN & RESPIRATORY FAILURE. WE IMMEDIATELY REQUESTED FOR THE PHOTO OF THE DEVICE & SUPPOSEDLY DEFECT SAMPLE TO RETURN FOR INVESTIGATION. PHOTO OF THE DEVICE HAS BEEN RECEIVED. WE REVIEWED THE DHR & TESTING RECORDS FOR LOT# C22E043, CATALOG# SE0005-270C, MODEL#: 484041 ASSOCIATED WITH THE ADVERSE EVENT, FOUND NO ISSUES OR DEVIATIONS FROM STANDARD OPERATING PROCEDURES AND SPECIFICATIONS. WE ALSO DID A RETROSPECTIVE REVIEW OF THE COMPLAINTS & FOUND NO OTHER REPORT OF ADVERSE EVENT ASSOCIATED WITH THIS LOT AND THERE WERE NO COMPLAINTS ATTRIBUTED TO SUCH ADVERSE EVENT OUTCOME. SINCE THE DEFECT DEVICE HAS NOT BEEN RETURNED YET BY (B)(6), A DETAILED INVESTIGATION IS NOT POSSIBLE. WE WILL ALSO PROVIDE UPDATES AS ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    PT PRESENTED TO CANCER CENTER FOR CONTINUOUS INFUSION OF 5 FU BY ELASTOMERIC PUMP ON (B)(6) 2023. RETURNED FOR DISCONNECT ON (B)(6) 2023 AND REPORTED THAT INFUSION COMPLETED IN 5 HRS. PT PRESENTED TO EMERGENCY DEPT ON (B)(6) 2022 WITH COMPLAINTS OF CHEST ABDOMINAL PAIN STATUS POST SYNCOPAL EPISODE. EXPIRED ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445604 SMARTEZ ELASTOMERIC PUMP PUMP, INFUSION, ELASTOMERIC MEB EPIC INTERNATIONAL (THAILAND) CO., LTD. 484041 C22E043

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Death