BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSAID IMPLANTABLE INFUSION PUMP

    MDR report key: 36713 · Received September 3, 1996

    Report

    Report Number
    1219454-1996-00384
    Event Type
    Injury
    Date Received
    September 3, 1996
    Date of Event
    August 5, 1996
    Report Date
    October 15, 1996
    Manufacturer
    STRATO/INFUSAID, INC.
    Product Code
    MDY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL VISUAL INSPECTION REVEALED THAT THE DEVICE SIDEPORT SEPTUM WAS PARTIALLY DISLODGED UPON RECEIPT. AFTER RE-SEATING THE DEVICE SIDEPORT SEPTUM, NORMAL USAGE WAS INDICATED ON BOTH THE CENTER AND SIDEPORT SEPTA WITH NO INTERNAL FRACTURE PLANE DAMAGE FOUND. THE DEVICE SIDEPORT WAS PATENT UPON FLUSHING AND APPROX. 5 ML OF CLOUDY, YELLOW FLUID WITH AMBER COLORED PARTICLES WAS COLLECTED WHICH TESTED POSITIVE FOR BLOOD WAS FOUND IN THE DEVICE CAPILLARY TUBE FLOWPATH. AFTER REMOVING APPROX. ONE HALF OF THE DEVICE CAPILLARY TUBING, PATENCY WAS RESTORED AND THE DEVICE FLOWED 189% OF THE ORIGINAL MANUFACTURED FLOWRATE. LEAK TESTING CONFIRMED THE DEVICE DID NOT LEAK. NO OTHER DEFECTS OR ANOMALIES WERE FOUND DURING ANALYSIS. AS PART OF CO'S INVESTIGATION OF THIS EVENT, A REVIEW OF THE DEVICE HISOTRY RECORD AND A TREND ANALYSIS WERE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND DID NOT IDENTIFY ANY MANUFACTURING VARIANCES IN RELATION TO THIS EVENT. A TREND ANALYSIS WAS ALSO PERFORMED ON SIMILAR INCIDENTS INVOLVING THIS CATALOG NUMBER AND HAS NOT IDENTIFIED ANY TRENDS. THIS ANALYSIS HAS CONFIRMED THE SURGEON'S COMPLAINT OF "SEPTUM DISLODGEMENT". OVERPRESSURIZATION IS SUSPECTED TO BE ATTRIBUTABLE TO THE SEPTUM DISLODGEMENT; HOWEVER, THE PRECISE CAUSE OF THE SEPTUM DISLODGEMENT CANNOT BE CONCLUSIVELY DETERMINED BO CO'S ANALYSIS. NO FURTHER INFO IS AVAILABLE. THE MFR IS NOW CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    ON 8/5/96, WHILE IN THE OPERATING ROOM WITH THE PT, THE SURGEON CONTACTED A MFR REPRESENTATIVE AND STATED THAT THE DEVICE SIDEPORT SEPTUM IS "DISLODGED FROM THE DEVICE AND LYING IN THE SIDEPORT AT A 90 DEGREE ANGLE." "BLOOD HAS BEEN LEAKING FROM THE DEVICE SIDEPORT". THE DEVICE WAS IMPLANTED WITHIN THE HEPATIC ARTERY, ON 7/9/96, FOR TREATMENT OF LIVER CANCER. A METHYLENE BLUE PERFUSION SCAN WAS PERFORMED WHICH CONFIRMED ADEQUATE PERFUSION TO BOTH LOBES OF THE LIVER. THE DEVICE WAS ACCESSED SATISFACTORILY ON 7/12/96. THE PT WAS DISCHARGED FROM THE HOSP ON 7/17/96. ON 7/19/96, THE PT WAS SEEN BY THE PHYSICIAN WITHOUT ANY DIFFICULTIES NOTED. ON 7/22/96, THE PT WAS SEEN BY THE ONCOLOGIST AND SEROMA/HEMATOMA WAS NOTED. THE PHYSICIAN DRAINED 400CC'S OF FLUID FROM THE DEVICE POCKET SITE ON 7/29/96. ON 7/30/96, THE ONCOLOGIST WAS UNABLE TO ACCESS THE DEVICE DUE TO A LARGE HEMATOMA. ON 8/2/96 THE HEMATOMA WAS STILL PRESENT. THE PT WAS SCHEDULED FOR INSERTION AND DRAINAGE AT ANOTHER FACILITY ON 8/5/96. UPON OPENING THE DEVICE POCKET, THE SURGEON WAS ABLE TO VISUALIZE THE SIDEPORT DISLODGMENT. AS A RESULT, THE DEVICE WAS EXPLANTED. A NEW DEVICE WAS ORDERED AND SURGERY SCHEDULED FOR 8/6/96 FOR IMPLANT OF THE REPLACEMENT DEVICE. A MFR NURSE CONTACTED BOTH PHYSICIANS' OFFICES ON 8/5/96 AND CONFIRMED THAT THE DEVICE HAD NOT BEEN ACCESSED IN EITHER OF THEIR OFFICES.

    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 71 YR Required Intervention