BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSPAC® IV MONITORING KIT WITH SAFESET¿ RESERVOIR AND BLOOD SAMPLING PORT, 60"

    MDR report key: 8510967 · Received April 12, 2019

    Report

    Report Number
    9617594-2019-00115
    Event Type
    Malfunction
    Date Received
    April 12, 2019
    Date of Event
    March 21, 2019
    Report Date
    March 22, 2019
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    DRS
    PMA / PMN Number
    K052828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT OF TUBING SEPARATION WAS CONFIRMED BASED ON PHOTOGRAPHIC EVIDENCE PROVIDED BY THE CUSTOMER. THE PICTURE SHOWED A 10" LENGTH OF TUBING SEPARATED FROM THE MALE AND FEMALE LUERS. A DEVICE HISTORY REVIEW OF TWO ADDITIONAL LOTS, 3732972 AND 3851678, SHOWED NO RELEVANT NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE PROBABLE CAUSE OF THE TUBING SEPARATION CANNOT BE DETERMINED WITHOUT THE SAMPLE BEING RETURNED FOR A FULL INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED TO THE MANUFACTURER FOR FURTHER EVALUATION BUT HAS NOT YET BEEN RECEIVED. THERE WERE TWO POSSIBLE LOTS REPORTED. PLEASE SEE BELOW: (B)(4): MANUFACTURING DATE: 07-01-2018 AND EXPIRY DATE: 07-01-2021. (B)(4): MANUFACTURING DATE: 11-01-2018 AND EXPIRY DATE: 11-01-2021.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NEW DEVICE WAS OPENED TO SWITCH TUBING ON A PATIENT WITH AN ARTERIAL LINE AND THE NEW SET COMPLETELY FELL APART. THE SCREW ON THE DISTAL PORTION THAT CONNECTS TO THE CATHETER BETWEEN THE TWO CONNECTORS PULLED RIGHT OUT OF THE CONNECTION LIKE IT WAS NOT ATTACHED TO THE TUBING. THE CLINICIAN REPORTED THAT THE PATIENT WAS BLEEDING HOWEVER THE BLOOD LOSS WAS NOT SIGNIFICANT SINCE THE NURSE WAS IN THE ROOM AND CAUGHT IT IMMEDIATELY, THE PATIENT WAS REPORTED TO NOT HAVE EXSANGUINATED. THERE WAS PATIENT INVOLVEMENT, AND THE REPLACEMENT OF THE ARTERIAL LINE WAS REQUIRED. THERE WAS ALSO A NON-CRITICAL DELAY IN THERAPY SINCE THEY WERE ABLE TO MONITOR THE PATIENT¿S BLOOD PRESSURE IN DIFFERENT WAYS THAT WERE NOT INCLUDED IN THIS REPORT. THERE IS NO ADDITIONAL INFORMATION KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301793 TRANSPAC® IV MONITORING KIT WITH SAFESET¿ RESERVOIR AND BLOOD SAMPLING PORT, 60" INVASIVE BLOOD PRESSURE MONITORING DISPOSABLES DRS ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1