BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSAID IMPLANTABLE INFUSION PUMP

    MDR report key: 39453 · Received September 20, 1996

    Report

    Report Number
    1219454-1996-00417
    Event Type
    Injury
    Date Received
    September 20, 1996
    Date of Event
    August 19, 1996
    Report Date
    September 20, 1996
    Manufacturer
    STRATO/INFUSAID INC
    Product Code
    MDY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR AND HAS BEEN ANALYZED AS FOLLOWS: THE CENTER AND SIDEPORT SEPTA SHOWED ONLY NEEDLE PENETRATION MARKS WITH NO EVIDENCE OF INTERNAL DAMAGE. THE 3.5 INCH CATHETER WAS FREE OF CUTS, TEARS OR HOLES. THE SIDEPORT/CATHETER WERE PATENT. THIS PUMP FLOWED WITHOUT ORIGINAL MFR FLOW RATE SPECIFICATIONS AS RECEIVED. LEAK TESTING CONFIRMED THE DEVICE DID NOT LEAK. NO DEFECTS OR ANOMALIES WERE FOUND DURING THE MFR'S ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD AND A TREND ANALYSIS WERE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND DID NOT IDENTIFY ANY MFG VARIANCES IN RELATION TO THIS EVENT. A TREND ANALYSIS WAS ALSO PERFORMED INVOLVING THIS CATALOG NUMBER AND HAS NOT IDENTIFIED ANY TRENDS. BASED ON THE INFO AVAILABLE, THE SURGEON ELECTED TO REPLACE THE DEVICE RATHER THAN RISK A POTENTIAL DEVICE MALFUNCTION IN THE FUTURE, AFTER THE DEVICE SIDEPORT SEPTUM HAD BEEN ACCESSED WITH THE INCORRECT NEEDLE. NO FURTHER INFO IS AVAILABLE. THE MFR IS NOW CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    ON 8/23/96, THE FACILITY O.R. MATERIALS MANAGEMENT CONTACTED A MANUFACTURER REP AND REPORTED THAT THE PHYSICIAN HAD IMPLANTED THE DEVICE ON 8/19/96. IT WAS ADDITIONALLY STATED THAT DURING SURGERY, THE DEVICE CATHETER WAS ATTACHED TO THE HEPATIC ARTERIAL SUPPLY. AFTER DOING FLUORESCEIN DYE BOLUS VIA THE DEVICE SIDEPORT, THE SURGEON REALIZED THAT HE HAD USED A STRAIGHT, NON-HUBER NEEDLE RATHER THAN AN ANTI-CORING HUBER POINT NEEDLE. AS A RESULT, RATHER THAN RISK DEVICE MALFUNCTION, THE DEVICE WAS REMOVED AND ANOTHER DEVICE WAS OBTAINED FROM FACILITY INVENTORY TO COMPLETE THE SURGERY, NO FURHTER INFO IS AVAILABLE.

    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 Other