BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 7113354 · Received December 13, 2017

    Report

    Report Number
    1314492-2017-03211
    Event Type
    Malfunction
    Date Received
    December 13, 2017
    Date of Event
    June 14, 2016
    Report Date
    April 2, 2018
    Manufacturer
    BAXTER HEALTHCARE - MEDINA
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH: (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE REPORTED DEVICE WAS NOT RETURNED TO BAXTER FOR SERVICE AFTER THE ALLEGED FENTANYL OVER-INFUSION OCCURRED ON (B)(6) 2016, A REVIEW OF THE SERVICE HISTORY RECORDS FOR DEVICE 854012 REVEALED THE DEVICE WAS FOUND TO OVER-INFUSE WHEN IT WAS EVALUATED IN SEPTEMBER 2017 AND THE CAUSE OF THE OVER-INFUSION WAS DETERMINED TO BE A WORKMANSHIP FAILURE DURING MANUFACTURING WHICH RESULTED IN NO GREASE BEING APPLIED TO THE CAM LOBES AND THEREFORE ABNORMAL WEAR ON THE CAM LOBES AND PUSHERS. THE EVENT HISTORY LOG (EHL) WAS DOWNLOADED ON (B)(6) 2017, WHEN THE DEVICE WAS RECEIVED FOR SERVICE. THE EHL DOWNLOADED ON (B)(6) 2017 DOES INCLUDE EVENTS FROM THE REPORTED EVENT DATE OF (B)(6) 2016. ON (B)(6) 2016, A FENTANYL INFUSION WAS PROGRAMMED WITH A DOSE OF 2MCG/KG/HR, A RATE OF 4.2ML/HR, AND A VOLUME TO BE INFUSED (VTBI) OF 50ML AND PUMP RUN WAS SELECTED AT 19:39. ALSO AT 19:39, THE TITRATE KEY WAS PRESSED AND THE VTBI WAS UPDATED TO 35ML. THE USER STOPPED THE INFUSION PROCESS AT 19:53 AND THE VTBI WAS 34ML AND THE GIVEN VOLUME WAS 1ML. THE SET WAS UNLOADED AND THE FENTANYL INFUSION WAS NOT CONTINUED. IT IS REASONABLE TO SUGGEST, THAT IF THE DEVICE WAS OVER-INFUSING IN (B)(6) 2017 DUE TO ABNORMAL WEAR ON THE CAM LOBES AND PUSHERS, THEN THE DEVICE MAY HAVE ALSO OVER-INFUSED IN (B)(6) 2016 DUE TO ABNORMAL WEAR ON THE CAM LOBES AND PUSHERS. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPECTRUM PUMP EXPERIENCED AN OVER INFUSION DURING THERAPY. THE DEVICE WAS PROGRAMMED TO INFUSE 2MCG/KG/HR. WITHIN 10 MINUTES IT WAS NOTICED THAT THE BOTTLE WAS ALMOST EMPTY. NURSE PRESSED THE BUTTON TO STOP THE PUMP, BUT IT KEPT GOING. SHE THEN CLAMPED THE TUBING AND DISCONNECTED THE DRIP FROM THE PATIENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895148 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE - MEDINA N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR