BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 6451170 · Received March 31, 2017

    Report

    Report Number
    2016493-2017-00246
    Event Type
    Injury
    Date Received
    March 31, 2017
    Date of Event
    December 24, 2016
    Report Date
    March 10, 2017
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 1000ML B.BRAUN BAG NDC 0264-7800-09, LOT J6L781, EXP 03/19, 0.9% NACL INJECTION; 250ML B. BRAUN BAG NDC 0264-9587-20, LOT J6J114N, EXP 01/19, HEPARIN SODIUM; NON-CFN EXTENSION SET, THERAPY DATE (B)(6) 2016. THE CUSTOMER¿S REPORT OF A HEPARIN OVERINFUSION WAS NOT CONFIRMED OR REPLICATED. PHYSICAL INSPECTION NOTED THE DEVICE TO BE IN FAIR CONDITION WITH THE INSTRUMENT SEAL INTACT. OBSERVED ANOMALIES INCLUDED A CRACK IN THE LOWER DOOR HINGE AND DULL IUI CONNECTORS. THE REAR CASE WAS OBSERVED TO HAVE SEVERAL DENTS AND CHIPS. PIECES THAT COULD BE HEARD RATTLING INSIDE THE DEVICE WERE IDENTIFIED AS PIECES OF CRACKED BEZEL POSTS. THE BEZEL WAS OBSERVED TO BE CRACKED UNDERNEATH THE MEMBRANE FRAME AT ALL 6 POSTS THAT SECURE THE MECHANISM ASSEMBLY TO THE BEZEL. THERE WERE NO ANOMALIES OBSERVED WITH THE PRIMARY SET. ANALYSIS OF THE PCU EVENT SHOWS THAT AT 8:50 PM ON (B)(6) 2016 THE DEVICE WAS PROGRAMMED TO INFUSE HEPARIN 25000UNIT/250ML AT A RATE OF 10ML/HR. THE INFUSION CONTINUED UNTIL 11:36 PM WHEN THE DEVICE WAS CHANNELED OFF. THERE WERE NO ALARMS PRIOR TO THE DEVICE BEING CHANNELED OFF. THE VOLUME RECORDED AS BEING INFUSED WAS 27.67ML. FUNCTIONAL TESTING PERFORMED FOUND THE PUMP MODULE TO BE DELIVERING FLUID OUT OF SPECIFICATION (UNDER INFUSING). THERE WERE NO LEAKS OBSERVED WITH THE SET. THE ROOT CAUSE OF THE CUSTOMER¿S REPORT OF A HEPARIN OVERINFUSION WAS NOT IDENTIFIED.

    Additional Manufacturer Narrative · 1

    CORRECTION ON INITIAL REPORT: IN SUMMARY, THE FORMAL INVESTIGATION IDENTIFIED TWO ROOT CAUSES FOR THE SEPARATED/BROKEN BEZEL BOSS ISSUE. MANUFACTURING ¿DRIVEN POLYMER MATERIAL DEGRADATION LED TO REDUCED MECHANICAL PROPERTIES. ENVIRONMENTAL STRESS CRACKING (ESC) FROM CONTAMINATES INTRODUCED TO THE BOSS BY THE METAL INSERT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HEPARIN WAS PROGRAMMED TO INFUSE AT 1000U/HR. AFTER APPROXIMATELY 3 HOURS THE BAG WAS NOTED TO BE EMPTY AND THE PATIENT HAD LAB VALUE CHANGES (INCREASED ANTI-XA) DUE TO THIS EVENT. THERE IS NO REPORT OF LONG STANDING PATIENT HARM.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HEPARIN WAS PROGRAMMED TO INFUSE AT 1000U/HR. AFTER APPROXIMATELY 3 HOURS THE BAG WAS NOTED TO BE EMPTY AND THE PATIENT HAD LAB VALUE CHANGES (INCREASED ANTI-XA) DUE TO THIS EVENT. THERE IS NO REPORT OF LONG STANDING PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231125 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 8100,8015,(2)2426-0007, TD (B)(6) 2016