BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUNMED LLC

    MDR report key: 16523210 · Received March 10, 2023

    Report

    Report Number
    1314417-2023-00006
    Event Type
    Injury
    Date Received
    March 10, 2023
    Date of Event
    January 16, 2023
    Report Date
    March 10, 2023
    Manufacturer
    SUNMED HOLDINGS LLC
    Product Code
    KZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRESSURE BAG LEAKING PRESSURE COULD DELAY OR INTERRUPT THERAPY. THIS IS ATTACHED TO AN ARTERIAL LINE AND CAN IMPACT PATIENT THERAPY. THE PATIENT WAS IMPACTED DUE TO RESPIRATORY DISTRESS SUMMARY: INVESTIGATION TO REPORTED DEFECT IDENTIFIES THAT AIR IN THE FLUID LINES COULD NOT BE CAUSED BY PIB DEVICE. AIR IN THE PIB DOES NOT ENTER FLUID BAG/FLUID LINES. IMAGE OF DEVICE WAS SHARED WITH CUSTOMER AND INVESTIGATION FORM COMPLETED AND RETURNED TO CUSTOMER. RA: PRODUCT DESIGN DOES NOT CONSTITUTE ANY ADDITIONAL RISK NOT TAKEN INTO ACCOUNT BY RMA-20012A, RISK ID R15 - RAPID INFUSION MAY CAUSE IV BAG TO BURST.

    Additional Manufacturer Narrative · 0

    THE PRESSURE BAG LEAKING PRESSURE COULD DELAY OR INTERRUPT THERAPY. THIS IS ATTACHED TO AN ARTERIAL LINE AND CAN IMPACT PATIENT THERAPY. THE PATIENT WAS IMPACTED DUE TO RESPIRATORY DISTRESS.

    Description of Event or Problem · 0

    CUSTOMER BELIEVES AIR COULD BE LOCATED WITHIN THE LINES DURING USE. CHILD: TACHYCARDIC, RESPIRATORY DISTRESS FOR SHORT TIME, SCAN DID NOT CONFIRM AIR EMBOLISM: ADULT: TACHYCARDIC, RESPIRATORY DISTRESS FOR SHORT TIME, SCAN DID NOT CONFIRM AIR EMBOLISM

    Description of Event or Problem · 0

    CUSTOMER BELIEVES AIR COULD BE LOCATED WITHIN THE LINES DURING USE. 1 - CHILD: TACHYCARDIC, RESPIRATORY DISTRESS FOR SHORT TIME, SCAN DID NOT CONFIRM AIR EMBOLISM 1 - ADULT: TACHYCARDIC, RESPIRATORY DISTRESS FOR SHORT TIME, SCAN DID NOT CONFIRM AIR EMBOLISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1148107 SUNMED LLC PREMIERPRO 1000ML PRESSURE INFUSION BAG, MESH BACK KZD SUNMED HOLDINGS LLC 8808 220800630

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other