BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 6421585 · Received March 21, 2017

    Report

    Report Number
    2016493-2017-00203
    Event Type
    Malfunction
    Date Received
    March 21, 2017
    Date of Event
    February 23, 2017
    Report Date
    February 23, 2017
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 1000 ML BAXTER BAG, NDC 0338-0221-04, LOT: Y220814, EXP: JUN18, PLASMA-LYTE-A INJECTION; 100 ML BAXTER BAG, NDC 61553-051-48, LOT: 2B8011, EXP: 03-25-2017, CALCIUM GLUCONATE 2G; 500 ML BAXTER BAG, NDC 61553-266-03, LOT: Y220368, EXP: MAR 18, NOREPINEPHRINE; PRI TUBING, THERAPY DATE: (B)(6) 2017. THE AFFECTED DEVICE HAS BEEN RECEIVED AND THE INVESTIGATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    CONCLUSION CODE: FIELD LEFT BLANK- NO AVAILABLE CODE FOR UNDETERMINED OR UNKNOWN CAUSE. THE REPORT OF A CHANNEL DISCONNECTED ERROR OCCURRING DURING AN INFUSION WAS CONFIRMED VIA LOG ANALYSIS BUT THE ERROR COULD NOT BE DUPLICATED DURING THE INVESTIGATION. PHYSICAL INSPECTION OF THE DEVICE NOTED NO ISSUES WITH THE RIGHT IUI CONNECTOR ON THE PUMP MODULE SN (B)(4) THAT EXPERIENCED THE CHANNEL DISCONNECT EVENT. THE LEFT IUI CONNECTOR ON THE PUMP MODULE THAT WAS NOTED TO BE THE CHANNEL B SN (B)(4) AND WOULD HAVE INTERFACED WITH THE RIGHT IUI ON THE ERRORING PUMP MODULE DID NOT HAVE ANY SIGNIFICANT CONTAMINATION PRESENT TO BE CONSIDERED THE SOURCE. AT THE TIME OF THE ERROR EVENT THE CHANNEL A PUMP WAS INFUSING AT THE RATE OF 75ML/H. THE USER HAD PROGRAMMED THE PUMP MODULE TO INFUSE IV FLUID FROM THE DRUG LIBRARY. WHAT DRUG WAS ACTUALLY INFUSING COULD NOT BE DETERMINED WITH CERTAINTY; THE PUMP MODULE WAS RECEIVED WITH A PRIMARY BAG OF PLASMA-LYTE A AND A SECONDARY BAG ATTACHED OF CALCIUM GLUCONATE 2 GRAM WITH BOTH HAVING RESIDUAL FLUID IN THEM. FUNCTIONAL TESTING WAS PERFORMED THE SYSTEM PHYSICALLY MANIPULATED DURING OPERATION WITH NO REPLICATION OF A CHANNEL DISCONNECTED ERROR OCCURRING AND THERE WERE NO SIGNS OF CONTINUITY RELATED ISSUES OCCURRING AT THE INTERFACED IUI CONNECTIONS. THE ROOT CAUSE FOR THE CHANNEL DISCONNECTED ERROR EVENT COULD NOT BE DETERMINED DURING THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A CHANNEL DISCONNECT OCCURRED DURING A PATIENT¿S UNSPECIFIED VASOACTIVE MEDICATION INFUSION. MEDICATIONS INFUSING ON OTHER CHANNELS WERE PLASMA-LYTEA WITH A CALCIUM GLUCONATE PIGGYBACK, PRECEDEX, AND NOREPINEPHRINE. THE USER OBTAINED A NEW DEVICE SET UP TO CONTINUE THE PATIENT¿S MEDICATIONS. THERE WAS NO REPORT OF PATIENT HARM, DEVICES WERE SEQUESTERED AND SENT TO BIOMED FOR EVALUATION WHERE CORROSION WAS OBSERVED ON ONE OF THE IUI CONNECTORS. ALTHOUGH REQUESTED, NO ADDITIONAL EVENT DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204510 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 (3)8100,8015,(3)2420-0007,72213N, TD (B)(6) 2017