BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 7248108 · Received February 7, 2018

    Report

    Report Number
    2016493-2018-00137
    Event Type
    Malfunction
    Date Received
    February 7, 2018
    Date of Event
    July 9, 2017
    Report Date
    January 26, 2018
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADMITTING DIAGNOSIS: PANCREATIC CANCER WITH METASTASIS. THE CUSTOMER¿S REPORT THAT THE DEVICE INFUSED THE NORMAL SALINE OVER 4 HOURS INSTEAD OF OVER 9-10 HOURS WAS NOT CONFIRMED. PHYSICAL INSPECTION OF THE DEVICE NOTED THE INSTRUMENT SEAL NOT INTACT. BESIDES SLIGHT FLUID INGRESS IN THE REAR CASE AND AROUND THE BEZEL ASSEMBLY AND DULL IUIS, NO OTHER ANOMALIES WERE OBSERVED. REVIEW OF THE PCU EVENT LOG SHOWS THAT A PRIMARY INFUSION OF IV FLUIDS (DRUG ID:3) WAS PROGRAMMED TO INFUSE AT DIFFERENT RATES THAT WOULD HAVE COMPLETED IN APPROXIMATELY 10 AND 9 HOURS. EX.RATE OF 100ML/H FOR MULTIPLE VTBIS OF 1000, 900, 940, AND 850ML WAS STOPPED BY USER AFTER 13 HOURS 29 MINUTES 26 SECONDS WITH A TOTAL VOLUME INFUSED 1011.72ML. THERE WERE NO OBVIOUS PROGRAMMING ERRORS. FUNCTIONAL TESTING PERFORMED FOUND THE DEVICE DELIVERING FLUID WITHIN SPECIFICATION. THE ROOT CAUSE OF THE CUSTOMER¿S REPORT THAT PUMP MODULE OVER INFUSED WAS NOT IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE DEVICE WAS PROGRAMMED FOR 100 ML/HOUR, AND THE DEVICE INFUSED THE IV FLUIDS OVER 4 HOURS INSTEAD OF OVER 9-10 HOURS. THERE WAS NO REPORT OF PATIENT HARM.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE DEVICE WAS PROGRAMMED FOR 100 ML/HOUR, AND THE DEVICE INFUSED THE NORMAL SALINE OVER 4 HOURS INSTEAD OF OVER 9-10 HOURS. THERE WAS NO DETECTABLE HARM TO THE PATIENT. A LOCATION OF THE MEDICAL UNIT WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE DEVICE WAS PROGRAMMED FOR 100 ML/HOUR, AND THE DEVICE INFUSED THE NORMAL SALINE OVER 4 HOURS INSTEAD OF OVER 9-10 HOURS. THERE WAS NO DETECTABLE HARM TO THE PATIENT. A LOCATION OF THE MEDICAL UNIT WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    NO DEVICE WILL BE RETURNED PER CUSTOMER. THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED BECAUSE THE DEVICE WAS NOT RETURNED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED.

    Additional Manufacturer Narrative · 1

    DATE RECEIVED BY MANUFACTURER: (01/26/2018).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN OVER INFUSION OF AN UNSPECIFIED SOLUTION. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93207 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR 8100,2420-0007, THERAPY DATE (B)(6) 2017| 8100,8015| PRI TUBING,8015, THERAPY DATE UNK