BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRBR GEMSTR 1.2 FLTR PP Y-SITE 96IN

    MDR report key: 3201627 · Received June 26, 2013

    Report

    Report Number
    9615050-2013-01754
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 27, 2013
    Report Date
    May 27, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K060806
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION IS COMPLETE. THE DEVICE WAS NOT RECEIVED. DURING THE INVESTIGATION, NO CAUSES FOR THE CUSTOMER'S REPORTED COMPLAINT OF LEAK COULD BE DETERMINED. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. 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 AIR IN THE TUBING DISTAL TO THE AIR ELIMINATING FILTER. ON (B)(6) 2013, AT AN UNSPECIFIED TIME, THE NURSE PRIMED THE TUBING SET WITH AN UNSPECIFIED SOLUTION AND THE SECURE LOCK MALE ADAPTER OF THE TUBING SET WAS CONNECTED TO A FEMALE ADAPTER OF THE PATIENT'S IV ACCESS SITE. THE GEMSTAR PUMP WAS PROGRAMMED TO DELIVER 2 G CLOXACILLIN, WITH A 120 ML DOSE AMOUNT, FOR A DURATION OF 1 HOUR, WITH A DOSE FREQUENCY OF EVERY 5 HOURS, FOR 4 DOSES, AT A KEEP VEIN OPEN (KVO) RATE OF 2 ML/HR, WITH A SOLUTION CONTAINER SIZE OF 532 ML. ON (B)(6) 2013 AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF AIR SEGMENTS WERE NOTED IN THE TUBING DISTAL TO THE AIR ELIMINATING FILTER OF THE TUBING SET. IT WAS REPORTED THAT NO AIR WAS NOTED IN THE TUBING, PROXIMAL TO THE AIR ELIMINATING FILTER OF THE TUBING SET. NO AIR WAS DELIVERED TO THE PATIENT. IT WAS REPORTED THAT THE HOMECARE PATIENT REMOVED THE AIR FROM THE TUBING SET BY PURGING AND "FLICKING THE FILTER" AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289920 MICRBR GEMSTR 1.2 FLTR PP Y-SITE 96IN 80 FRN HOSPIRA COSTA RICA LTD. NA 270535H

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR