BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSAID IMPLANTABLE INFUSION PUMP

    MDR report key: 38058 · Received September 10, 1996

    Report

    Report Number
    1219454-1996-00403
    Event Type
    Injury
    Date Received
    September 10, 1996
    Date of Event
    August 12, 1996
    Report Date
    September 10, 1996
    Manufacturer
    STRATO/INFUSAID, INC.
    Product Code
    MDY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS IMPLANTED ON 5/24/95, FOR INFUSION OF FUDR THROUGH THE SUBCLAVIAN VEINS (NOTE: INFUSION OF FUDR THRU SUBCLAVIAN VEIN IS NOT AN INDICATION FOR THE MFR'S INTENDED USE). ON 8/13/96, THE FACILITY'S PHARMD CONTACTED A MFR CLINICAL SPECIALIST WITH CONCERNS ABOUT ACCURATE DRUG DOSING VIA THE DEVICE DUE TO FLOW RATE VARIATIONS OF THIS DEVICE. THE FACILITY'S PHARMD STATED THAT FOLLOWING FLOW RATE (FR) INFO: 6/19/96, FR=1.53ML/DAY, 7/29/96, 1.93 ML/DAY AND ON 8/12/96, FR=1.14 ML/DAY. THE HEPARIN CONCENTRATION =80,000U/50ML. THE FACILITY'S PHARMD ALSO STATED THAT THE REFILL PERSON USED THE MFR'S 22GA NEEDLE, BUT NOT THE MFR'S REFILL KIT; HOWEVER, THE REFILL PERSON AND THE EQUIPMENT ARE CONSISTENT. THE DEVICE SIDEPORT WAS CHECKED FOR PATENCY WITH A HEPARIN/NORMAL SALINE FLUSH AND NO RESISTANCE WAS MET DURING INJECTION. THE DEVICE SIDEPORT HAD NOT BEEN PREVIOUSLY ACCESSED. NO DYE STUDY TO CHECK CATHETER PATENCY HAD BEEN PERFORMED SINCE THE DEVICE WAS IMPLANTED. THE MFR'S CLINICAL SPECIALIST RECOMMENDED A DYE STUDY THROUGH THE DEVICE SIDEPORT TO RULE OUT DEVICE CATHETER MIGRATION AND CONSIDER USE OF A THROMBOLYTIC IN THE DEVICE SIDEPORT. THE PHARMD STATED THAT THERE WAS NO AIR IN THE DEVICE RESERVOIR OR CHANGES IN THE PT'S ACTIVITIES OR ELEVATION. THE PT IS DOING WELL ON THE MEDICATION/TREATMENT, AND TREATMENT WOULD CONTINUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSAID IMPLANTABLE INFUSION PUMP Implant IMPLANTABLE INFUSION PUMP MDY STRATO/INFUSAID, INC. 400 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention