BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3870728 · Received June 12, 2014

    Report

    Report Number
    3004209178-2014-11520
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8780, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT THE PHYSICIAN WAS ABLE TO REFILL UNDER ULTRASOUND WITH NO PROBLEM. THE CULTURES WERE NEGATIVE. THE PATIENT WAS GETTING GOOD THERAPY AND DOING OKAY. THE PUMP WAS USED TO DELIVER HYDROMORPHONE, BUPIVACAINE AND KETAMINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS FILLING/ASPIRATION DIFFICULTIES. IT WAS NOTED THAT THERE WAS AN ASPIRATION ISSUE, SPECIFIED AS THE HEALTHCARE PROVIDER (HCP) THOUGHT THEY WERE IN THE REFILL PORT BUT WHEN THE HCP ASPIRATED A RETURN OF CLOUDY WHITE LIQUID WAS NOTICED. IT WAS REPORTED THAT THE HCP IMMEDIATELY ABORTED THE REFILL PROCEDURE DUE TO THE CONCERN THAT THE SYRINGE AND TUBING WERE THEN CONTAMINATED. IT WAS REPORTED THAT THERE WAS A REFILL ABORTED. IT WAS NOTED THAT THE ACTIONS REQUIRED AS A RESULT OF THE EVENT INCLUDED MEDICAL INTERVENTION EXPLAINED AS PROPHYLACTIC ANTIBIOTICS. IT WAS REPORTED THAT ACTION NOT TAKEN YET BUT PLANNED INCLUDED A CT SCAN AND CULTURES. IT WAS NOTED THAT THE HCP WAS CERTAIN THAT THEY WERE IN THE ACCESS PORT BUT WHEN THE HCP ASPIRATED CLOUDY WHITE LIQUID THE HCP DETERMINED THAT WAS NOT THE CASE AND ABORTED THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT PLANNED TO RETURN IN 10 TO 14 DAYS FROM THE TIME OF REPORT FOR A REFILL AFTER THE APPROPRIATE EVALUATION HAD BEEN DONE TO RULE OUT INFECTION. IT WAS NOTED THAT THE PATIENT¿S STATUS AT THE TIME OF REPORT WAS ALIVE ¿ NO INJURY. IT WAS REPORTED THAT THERE WERE NO PATIENT SYMPTOMS. IT WAS NOTED THAT THE PUMP WAS USED TO INFUSE AN UNKNOWN DRUG AT THE TIME OF REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347981 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00040 YR Required Intervention