BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGNATURE SE I INFUSION PUMP

    MDR report key: 9355006 · Received November 21, 2019

    Report

    Report Number
    2016493-2019-01543
    Event Type
    Malfunction
    Date Received
    November 21, 2019
    Date of Event
    October 23, 2019
    Report Date
    October 30, 2019
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K063288
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO INITIAL REPORT: B.4, G.4 REVISED TO (B)(6) 2019. THE CUSTOMER¿S REPORT OF AN UNDERINFUSION WAS NOT CONFIRMED. THE RECEIVED ADMINISTRATION SET WAS UNPACKED AND INSPECTED, AND NO DAMAGE, DEFICIENCIES OR TUBING KINKS WERE IDENTIFIED. THE ADMINISTRATION SET WAS REPEATEDLY INSTALLED AND REMOVED FROM THE PUMP WITHOUT ANY ISSUES IDENTIFIED. EACH TIME THE SET LOADED AND THE ACCUSLIDE OPENED CORRECTLY. A REVIEW OF THE EVENT LOG (SEE APPENDIX 3) IDENTIFIED THE FOLLOWING SEQUENCE OF EVENT HAVING OCCURRED ON (B)(6) 2019: 09:48 PUMP POWERED ON. 09:51 RATE OF 70.0ML/H ENTERED. VTBI OF 140.0ML ENTERED. INFUSION STARTED AND IMMEDIATELY ALARMED LATCH OPEN. INFUSION STARTED AT 70.0ML/H WITH A VTBI OF 140.0ML. PUMP ALARMED UPSTREAM OCCLUSION (VI = 0.6ML). INFUSION RESTARTED. INFUSION PAUSED. INFUSION RESTARTED. 11:51 PUMP ALARMED VTBI COMPLETED AND KVO STARTED (VI = 140.0ML). PUMP POWERED OFF. FUNCTIONAL TESTING OBSERVED NO ISSUES. AN INTERNAL INSPECTION IDENTIFIED: REAR CASE - BROKEN SCREW RETAINING PILLAR / SHOULDER. LOGIC BOARD RETAINING SCREW MISSING. LOOSE FRAGMENTS FROM THE REAR CASE SCREW RETAINING PILLAR / SHOULDER. A PERFORMANCE VERIFICATION PROCEDURE (PVP) WAS COMPLETED AND ALL RESULTS WERE WITHIN SPECIFICATION. THE PUMP WAS SUBJECTED TO A CONTINUOUS INFUSION FOR >48 HOURS WHICH WAS COMPLETED FAILURE FREE. THE INVESTIGATION IS INCONCLUSIVE AS A DEFICIENCY WAS NOT IDENTIFIED WITH THE PUMP OR THE ADMINISTRATION SET THAT WOULD HAVE RESULTED IN THE REPORTED UNDERINFUSION. THE SIGNATURE EDITION PUMPS ARE NO LONGER MANUFACTURED AND ARE CURRENTLY IN THE SUPPORT PHASE OF THE PRODUCT LIFE CYCLE.

    Description of Event or Problem · 0

    THE FEEDBACK SUGGESTS THAT AN INFUSION WAS PROGRAMMED AT A RATE OF 100ML/HR WITH 120ML VTBI (VOLUME TO BE INFUSED). IT WAS REPORTED THAT WHEN THE INFUSION HAD COMPLETED IT WAS OBSERVED THAT THE VOLUME INFUSED (VI) WAS 120ML, HOWEVER THE INFUSION BAG WAS STILL FULL. THERE WAS NO INFORMATION PROVIDED REGARDING PATIENT IMPACT.

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, THE AFFECTED DEVICES HAVE NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICES BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN INFUSION WAS SET FROM A FLUID BAG TO RUN AT RATE OF 70ML/HR WITH 140ML VTBI (VOLUME TO BE INFUSED). THE FEEDBACK SUGGESTS THAT WHEN THE INFUSION HAD COMPLETED IT WAS OBSERVED THAT THE INFUSION BAG WAS STILL FULL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1151919 SIGNATURE SE I INFUSION PUMP PUMP, INFUSION FRN CAREFUSION SIGNATURE SE I

    Patients

    Seq Age Sex Outcome Treatment
    1 72504EB| PRIMARY TUBING, THERAPY DATE 10/23/2019