BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLM A+ PLATINUM MODU

    MDR report key: 4102658 · Received August 28, 2014

    Report

    Report Number
    9615050-2014-05026
    Event Type
    Malfunction
    Date Received
    August 28, 2014
    Date of Event
    August 5, 2014
    Report Date
    August 5, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K070398
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED UNRESTRICTED FLOW. AT AN UNSPECIFIED TIME, AN UNSPECIFIED CHANNEL OF TE DEVICE WAS PROGRAMMED TO DELIVER AN UNSPECIFIED CONCENTRATION OF CARDIZEM 100ML AT A RATE OF 5 ML/DR WITH A VOLUME TO BE INFUSED (VTBI) OF 15 ML, AND THE DELIVERY WAS STARTED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. IT WAS REPORTED THAT THE PATIENT WAS BEING CLOSELY MONITORED VIA TELEMETRY. AFTER AN UNSPECIFIED LENGTH OF TIME, THE NURSE RETURNED TO CHECK THE PATIENT. AT THIS TIME, IT WAS REPORTED THAT PUMP DISPLAYED THAT 10.1ML HAD BEEN DELIVERED; HOWEVER, THE CUSTOMER CONTACT REPORTED THAT THE SOLUTION CONTAINER WAS EMPTY AND THE ENTIRE CONTENTS OF THE SOLUTION CONTAINER HAD BEEN DELIVERED TO THE PATIENT. IT WAS REPORTED THAT THE PUMP DID NOT ALARM FOR KVO AND BLEED BACK WAS NOTED. THE CUSTOMER CONTACT INDICATED THAT UNSPECIFIED LABS WERE DRAWN. NO SPECIFIC DETAILS WERE PROVIDED. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THE CUSTOMER CONTACT REPORTED THAT THE PATIENT'S CONDITION DID NOT CHANGE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REPORTED. DURING TESTING AT THE USER FACILITY, UNRESTRICTED FLOW WAS NOTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523863 PLM A+ PLATINUM MODU 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR