BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSAID IMPLANTABLE INFUSION PUMP

    MDR report key: 96171 · Received June 2, 1997

    Report

    Report Number
    1219454-1997-00230
    Event Type
    Injury
    Date Received
    June 2, 1997
    Date of Event
    May 6, 1997
    Report Date
    May 6, 1997
    Manufacturer
    STRATO/INFUSAID, INC.
    Product Code
    LKK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ON 6/5/97, THE FACILITY NURSE INFORMED THE MFR'S REP. THAT THE PATIENT IS CURRENTLY BEING TREATED WITH ORAL MEDICATION. THE DEVICE REMAINS IMPLANTED, BUT IS NOT BEING UTILIZED IN THE PATIENT'S THERAPY REGIMEN. THE DEVICE IS PRESENTLY BEING MAINTAINED WITH SALINE; HOWEVER, IF IN THE FUTURE THE PATIENT IS NOT RECEIVING ADEQUATE PAIN RELIEF, THE FACILITY MAY REVERT BACK TO USAGE OF THE DEVICE. SINCE THE DEVICE HISTORY RECORD. A TREND ANALYSIS WAS PERFORMED NOT IDENTIFIED. A REVIEW OF THE DEVICE HISTORY RECORD DID NTO REVEAL ANY MFG VARIANCES RELATED TO THIS EVENT. BASED ON THE INFO 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 CUSTOMER WILL BE NOTIFIED OF THE MFR'S FINDINGS. THE MFR IS NOW CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE DEVICE WAS IMPLANTED ON 12/08/1994, FOR THE INTRATHECAL INFUSION OF MORPHINE (NOTE: INTRATHECAL INFUSION OF MORPHINE WAS NOT THE MANUFACTURER'S (MFR) INDICATION FOR THE DEVICE'S INTENDED USE). ON 05/06/1997, THE FACILITY NURSE INFORMED THE MFR'S CLINICAL SPECIALIST THAT THE PATIENT NEVER REPORTED GOOD PAIN RELIEF; HOWEVER, THE MANAGING PHYSICIAN DID NOT INCREASE THE PATIENT'S MORPHINE DOSE. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND DIAGNOSED WITH DEPRESSION, SUICIDAL. DURING THE PATIENT'S STAY HE VOMITED AND ASPIRATED, LEADING TO MECHANICAL VENTILATION AND CARE IN THE INTENSIVE CARE UNIT (ICU). THE PATIENT HAS NOW BEEN EXTUBATED, BUT WAS VERY SLEEPY WHICH EFFECTED HIS RESPIRATIONS. THE FACILITY PHYSICIAN REQUESTED THAT THE MORPHINE BE REMOVED FROM THE PT'S DEVICE IMMEDIATELY. THE FACILITY NURSE CALLED FOR INSTRUCTION FOR ACCESSING THE DEVICE. THE MFR'S CLINICAL SPECIALIST FAXED THE FACILITY NURSE THE DEVICE REFILL INSTRUCTION SHEET AND THEN REVIEWED THE PROCEDURE WITH HER VIA TELEPHONE ALONG WITH THE DEVICE REFILL AND SIDEPORT CAUTIONS. FACILITY NURSE STATED THAT A MFR'S REFILL KIT AND NEEDLES WERE NOT AVAILABLE. THE MFR'S CLINICAL SPECIALIST DISCUSSED SUBSTITUTE SUPPLIES TO BE USED IN THIS URGENT SITUATION. THE MFR'S CLINICAL SPECIALIST ALSO PROVIDED THE FACILITY NURSE WITH THE MFR'S TELEPHONE NUMBER TO CALL IF ADDITIONAL ASSISTANCE OF A MFR NURSE WAS REQUIRED. THE DEVICE WAS TO BE REFILLED WITH PRESERVATIVE FREE NORMAL SALINE (PFNS) THAT DAY (05/06/97). THE FACILITY NURSE AND MFR'S CLINICAL SPECIALIST ALSO DISCUSSED APPROXIMATE DEVICE SIDEPORT TO CATHETER TIP VOLUME. THE MFR'S CLINICAL SPECIALIST OFFERED AN INSERVICE TO THE FACILITY, IF NEEDED. THE FACILITY NURSE STATED SHE WOULD DISCUSS THE INFORMATION WITH THE PHYSICIAN AND CONTACT THE MFR IF ADDITIONAL INFORMATION WAS NEEDED OR IF QUESTIONS ARISE. THE MFR'S CLINICAL SPECIALIST ASKED THE FACILITY NURSE IF THE EVENTS SURROUNDING THE PATIENT'S ADMISSION TO THE HOSPITAL OR COURSE WERE RELATED TO THE DEVICE. THE FACILITY NURSE STATED THAT TO HER KNOWLEDGE, THEY WERE NOT. THE FACILITY NURSE HAD NO FLOW RATE INFORMATION. THE FACILITY NURSE ASKED THE PROCEDURE FOR A DYE STUDY TO CHECK CATHETER PLACEMENT AND SIDEPROT CAUTIONS. THE MFR'S CLINICAL SPECIALIST MAILED THE FACILITY NURSE ADDITIONAL LITERATURE FOR NEXT DAY DELIVERY CONCERNING THE DEVICE FOR HER REVIEW. NO FURTHER DETAILS WERE PROVIDED AT THIS TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention