BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSAID IMPLANTABLE INFUSION PUMP

    MDR report key: 38683 · Received September 17, 1996

    Report

    Report Number
    1219454-1996-00416
    Event Type
    Injury
    Date Received
    September 17, 1996
    Date of Event
    August 22, 1996
    Report Date
    September 17, 1996
    Manufacturer
    STRATO/INFUSAID INC
    Product Code
    MDY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ON 9/25/96, THE FACILITY NURSE INFORMED THE MFR'S CLINICAL REP THAT DURING THE DEVICE REFILL ON 9/23/96, THE DEVICE YIELDED A FLOW RATE OF .8ML/DAY. THE EXPECTED FLOW RATE OF THE DEVICE IS .99ML/DAY AND THE DEVICE HAS BEEN FLOWING BETWEEN .8 AND .9ML/DAY. THE PATIENT'S MORPHINE DOSAGE WAS INCREASED TO 6.25MG/ML AND THE PATIENT WAS ADVISED TO CONTACT THE FACILITY IF SHE EXPERIENCED FURTHER PAIN. THE FACILITY NURSE STATED THAT THE PATIENT HAS NOT CALLED, SO SHE ASSUMES THAT THE PATIENT'S PAIN IS CONTROLLED. ON 10/2/96, THE MFR WAS INFORMED BY THE FACILITY NURSE THAT THERE ARE NO PLANS AT PRESENT TO EXPLANT THE DEVICE. THE DEVICE WILL REMAIN IMPLANTED FOR CONTINUED USE IN THE PATIENT'S THERAPY REGIMEN AND THE PATIENT'S MORPHINE DOSAGE WILL BE ADJUSTED ACCORDINGLY TO INCREASE THE PATIENT'S PAIN RELIEF. SINCE THE DEVICE REMAINS IMPLANTED, THE MFR'S INVESTIGATION OF THIS EVENT IS LIMITED TO A TREND ANALYSIS AND REVIEW OF THE DEVICE HISTORY RECORD. A TREND ANALYSIS WAS PERFORMED ON SIMILAR INCIDENTS FOR THIS CATALOG NUMBER AND A TREND WAS NOT IDENTIFIED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY MFG VARIANCES RELATED TO THIS EVENT FOR THIS DEVICE. BASED ON THE INFORMATION AVAILABLE AND DUE TO THE UNAVAILABILITY OF THE DEVICE, NO CONCLUSION CAN BE DRAWN AS TO THE CAUSE OF THIS EVENT. THE MFR'S INVESTIGATION OF THIS INCIDENT IS INCONCLUSIVE. NO FURTHER DETAILS ARE AVAILABLE. THE MFR IS NOW CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE DEVICE WAS IMPLANTED FOR INTRATHECAL INFUSION FOR TREATMENT OF PAIN. ON 8/22/96, A FACILITY NURSE CONTACTED THE MFR'S CLINICAL REP AND STATED THAT THE EXPECTED FLOW RATE OF THE DEVICE IS 0.99 ML/DAY; HOWEVER, THE ACTUAL FLOW RATE OF THE DEVICE HAS BEEN 0.9ML/DAY. TODAY 8/22/96, THE RETURN VOLUME= 22CC, REFILL PERIOD=35 DAYS AND THE DEVICE FLOW RATE=0.8ML/DAY. THE PT HAS A PAST HISTORY OF A DEVICE CATHETER REVISION DUE TO DISPLACEMENT OF THE DEVICE CATHETER AND HAS BEEN COMPLAINING OF PAIN RECENTLY. THE PT'S MORPHINE DOSE WAS INCREASED FROM 3.5MG/DAY TO 4MG/DAY. THE FACILITY NURSE STATED THAT IN THE PAST THE PT COMPLAINED OF PAIN, THE DEVICE SIDEPORT WAS ASPIRATED AND THE FLUID OBTAINED TESTED POSITIVE FOR CEREBRAL SPINAL FLUID (CSF). THE MFR'S CLINICAL REP EXPLAINED THAT ASPIRATION OF EITHER OF THE DEVICE SEPTA IS NOT RECOMMENDED. THE MFR'S CLINICAL REP SUGGESTED THAT THE DEVICE SIDEPORT BE FLUSHED WITH NORMAL SALINE (NS) TO SEE IF IT FLUSHES EASILY AND QUESTIONED THE FACILITY NURSE AS TO WHETHER THIS PROCEDURE WOULD BE PERFORMED BY THE PHYSICIAN DUE TO A POSSIBLE BOLUS DOSE OF MORPHINE. ADDITIONALLY, THE MFR'S CLINICAL REP ALSO STATED THAT THE DEVICE SHOULD BE RINSED WITH TWO(2) 50CC SYRINGES OF PRESERVATIVE FREE NORMAL SALINE (PFNS) TO RID THE DEVICE SYSTEM OF AIR. IF RESISTANCE IS MET AND THE DEVICE FLOW RATE DOES NOT REVERT TO NORMAL, A DYE STUDY OF THE DEVICE SIDEPORT SHOULD BE PERFORMED. THE FACILITY NURSE STATED SHE WOULD TALK TO THE PHYSICIAN.

    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 31 YR Required Intervention