BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEHPFREE PRI GRAV SET 1 SS VLV

    MDR report key: 10646213 · Received October 7, 2020

    Report

    Report Number
    9616066-2020-20038
    Event Type
    Injury
    Date Received
    October 7, 2020
    Date of Event
    June 23, 2020
    Report Date
    October 13, 2020
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    37613203020900
    PMA / PMN Number
    K820278
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED ON MODEL 41173E BECAUSE A LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. DUE TO NO SAMPLE BEING RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED AND A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DEHPFREE PRI GRAV SET 1 SS VLV HAD AIR IN THE LINE WHICH LIKELY RESULTED IN AIR EMBOLISM. THIS OCCURRED ON 2 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 41173E BATCH NO: UNKNOWN . IT WAS REPORTED THAT CT OF CHEST/ABDOMEN/PELVIS REVEALED LIKELY A "IATROGENIC EMBOLISM" IN HEART AND PULMONARY ARTERIAL TRUNK. EVENT DESCRIPTION PER EMAIL STATES: CT CHEST/ABDOMEN/PELVIS REVEALED LIKELY IATROGENIC AIR EMBOLISM IN HEART AND PULMONARY ARTERIAL TRUNK. THIS IS THE SECOND SIMILAR EVENT IN A 2 MONTH TIME FRAME THAT COULD BE ATTRIBUTED TO IV TUBING. BD CURRENTLY HAS A RECALL ON OTHER IV TUBING THAT CAN RESULT IN AIR EMBOLISM. FDA SAFETY REPORT ID#(B)(4).

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. THE INITIAL REPORTER ALSO NOTIFIED THE FDA ON 14 JULY, 2020. MEDWATCH REPORT # MW5095273. REPORT SOURCE OTHER: MEDWATCH REPORT. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DEHPFREE PRI GRAV SET 1 SS VLV HAD AIR IN THE LINE WHICH LIKELY RESULTED IN AIR EMBOLISM. THIS OCCURRED ON 2 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 41173E, BATCH NO: UNKNOWN. IT WAS REPORTED THAT CT OF CHEST/ABDOMEN/PELVIS REVEALED LIKELY A "IATROGENIC EMBOLISM" IN HEART AND PULMONARY ARTERIAL TRUNK. EVENT DESCRIPTION PER EMAIL STATES: CT CHEST/ABDOMEN/PELVIS REVEALED LIKELY IATROGENIC AIR EMBOLISM IN HEART AND PULMONARY ARTERIAL TRUNK. THIS IS THE SECOND SIMILAR EVENT IN A 2 MONTH TIME FRAME THAT COULD BE ATTRIBUTED TO IV TUBING. BD CURRENTLY HAS A RECALL ON OTHER IV TUBING THAT CAN RESULT IN AIR EMBOLISM. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1104647 DEHPFREE PRI GRAV SET 1 SS VLV INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 41173E UNKNOWN 37613203020900

    Patients

    Seq Age Sex Outcome Treatment
    1 Other