BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 7611446 · Received June 18, 2018

    Report

    Report Number
    3004209178-2018-13699
    Event Type
    Injury
    Date Received
    June 18, 2018
    Report Date
    October 3, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A FOREIGN HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER'S REPRESENTATIVE REGARDING A PATIENT WHO WAS RECEIVING MORPHINE (UNKNOWN CONCENTRATION AND DOSE) AND PRIALT (UNKNOWN CONCENTRATION AND DOSE) VIA AN IMPLANTABLE PUMP FOR AN UNKNOWN INDICATION FOR USE. IT WAS REPORTED A PROBLEM APPEARED DURING THE FILLING OF THE PUMP. THE EVENT DATE WAS UNKNOWN. IT WAS STATED THERE WERE VERY BIG DIFFERENCES BETWEEN THE VOLUMES ANNOUNCED BY THE N'VISION AND THE VOLUME FOUND IN THE PUMP. IT WAS STATED THE HCP HAD THE "IMPRESSION THAT THE PUMP FLIGHT. BECAUSE DURING FILLINGS, THERE WERE DIFFERENCES OF VERY IMPORTANT VOLUMES. INDEED, AT THE LEVEL OF THE SEPTUM, IT WOULD SEEM THAT THE PUMP FLIGHT. THE NURSES USE NEEDLES OF 20 GAUGES WHICH CERTAINLY CONNED THE SEPTUM AND CAUSED THE FLIGHTS." IT WAS STATED NO TROUBLESHOOTING WAS PERFORMED. BY PRECAUTION, THE HCP PREFERRED TO CHANGE THE PUMP AND CATHETER. THE REPLACEMENT OCCURRED ON (B)(6) 2018. WHEN PROMPTED FOR CONTRIBUTING FACTORS TO THE EVENT, THE RESPONSE WAS, "FOR TWO ONCE, THE STOMACH OF THE PATIENT PEARLED AT THE TIME OF THE FILLING." THE ISSUE WAS RESOLVED. THE PATIENT STATUS WAS ALIVE - NO INJURY. THE PUMP AND CATHETER WOULD BE RETURNED. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED. THE PATIENT WAS RECEIVING MORPHINE (1.5 MG/ML AT 0.6994 MG/DAY) AND PRIALT (4.0 MG/ML AT 1.8651 MG/DAY). THE VOLUME THE PUMP ANNOUNCED WAS 16.5 ML AND THE REPRESENTATIVE FOUND 0 ML. WHEN ASKED WHAT "PUMP FLIGHT" MEANS, THE REPRESENTATIVE RESPONDED, "NONE, IT¿S A MISTAKE." WHEN ASKED WHAT "CONNED THE SEPTUM" MEANS, THE REPRESENTATIVE RESPONDED, "THE SEPTUM IS THE CENTER OF THE PUMP." WHEN ASKED WHAT "STOMACH OF THE PATIENT PEARLED" MEANS, THE REPRESENTATIVE RESPONDED, "THE DRUG IS FLOWING THROUGH THE PATIENT'S SKIN." THE REPRESENTATIVE STATED THE MODEL OF THE PATIENT'S CATHETER WAS 8780. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453528 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention