BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEPORT VASCULAR ACCESS DEVICE

    MDR report key: 37201 · Received September 6, 1996

    Report

    Report Number
    1219454-1996-00401
    Event Type
    Injury
    Date Received
    September 6, 1996
    Date of Event
    June 25, 1996
    Report Date
    September 6, 1996
    Manufacturer
    STRATO/INFUSAID, INC.
    Product Code
    LJT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON 8/13/96, THE PT CONTACTED A MFR NURSE AND REPORTED THAT HER FIRST VASCULAR ACCESS DEVICE HAD BEEN EXPLANTED BECAUSE SHE WAS IN REMISSION AND THERE HAD NOT BEEN ANY PROBLEMS WITH THE DEVICE. THE PT THEN STATED THAT HER SECOND DEVICE HAD A TENDENCY TO CLOT AND SHE COULD FEEL PAIN IN HER SHOULDER UPON USE. THE FACILITY NURSE WAS UNABLE TO DRAW BLOOD AND "FORCED SALINE THROUGH" THE DEVICE, WHICH WAS EXTREMELY PAINFUL. IN ADDITION, THERE WAS SWELLING OVER THE DEVICE SITE. THE PT REPORTED THAT SHE WAS THEN SENT TO RADIOLOY, WHERE IT WAS NOTED THAT THE DEVICE CATHETER HAD "DISCONNECTED" FROM THE DEVICE BODY. THE PT WAS THEN TAKEN INTO SURGERY ON AN "EMERGENCY BASIS" WHERE THE DEVICE WAS EXPLANTED AND A NEW ONE WAS IMPLANTED. THE PT STATED THAT SHE WAS UNDER THE IMPRESSION THAT THE DEVICE WOULD BE RETURNED TO THE MFR, HOWEVER, THE DEVICE HAD NOT BEEN RETURNED TO DATE. THE PT STATED THAT SHE DOES NOT WANT THE MFR TO CONTACT HER PHYSICIAN AND DID NOT WANT TO BE PERCEIVED AS "A TROUBLEMAKER". THE PT STATED THAT SHE WOULD LIKE TO HAVE THE DEVICE EXAMINED, WITH A DETERMINATION OF "WHAT HAPPENED TO IT". THE MFR NURSE THEN CONTACTED THE FACILITY'S LEGAL AFFAIRS DEPARTMENT, AFTER TRYING UNSUCCESSFULLY TO OBTAIN INFO CONCERNING THE LOCATION OF THE DEVICE FROM THE OTHER DEPARTMENTS AT THE FACILITY. THE FACILITY LEGAL AFFAIRS REPRESENTATIVE STATED THAT THE PT WOULD BE CONTACTED CONCERNING THE LOCATION OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPORT VASCULAR ACCESS DEVICE Implant VASCULAR ACCESS DEVICE LJT STRATO/INFUSAID, INC. NA 427004

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death| H| R