BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7" PRESSURE INFUSION SET

    MDR report key: 4801654 · Received May 27, 2015

    Report

    Report Number
    2025816-2015-00049
    Event Type
    Malfunction
    Date Received
    May 27, 2015
    Date of Event
    April 1, 2015
    Report Date
    April 3, 2015
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    FINDINGS: THE INVOLVED DEVICE(S) WERE NOT RETURNED FOR ANALYSIS AND CONFIRMATION. THE 12514-01 WOULD HAVE BEEN PRE-TESTED/PRIMED PRIOR TO USE. UPON REMOVAL OF THE INVOLVED 12514-01, THE ATTENDING CLINICIANS DID NOT REPORT ANY VISUAL DEVICE/COMPONENT DAMAGES, DEFECTS AND OR ABNORMALITIES. THE EXACT CAUSES OF THE REPORTED EVENT/ PRODUCT ISSUE ARE UNK.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REPORTING MULTIPLE ISSUES (OCCLUSION/FLOW) WITH SET-UPS WHICH INCLUDED 12514-01 7" APPX 0.45 ML, PRESSURE INFUSION (400PSIG) EXT SET W/ MICROCLAVE CLEAR. THE INFO RECEIVED REPORTS THAT ON 04/01 DURING UNSPECIFIED CARDIAC PROCEDURE, ATTENDING PHYSICIAN" WAS ATTEMPTING TO INFUSE WHOLE BLOOD DURING A CARDIAC PROCEDURE. THE BLOOD WAS IN A 60CC SYRINGE, FASTENED TO A STOPCOCK WITHIN THE IV SYSTEM. THE EXTENSION SET WITH MICROCLAVE WAS OUT OF REACH UNDER THE SURGICAL DRAPES... (PHYSICIAN) WAS NOT ABLE TO PUSH THE BLOOD THROUGH THE SYSTEM. AS PART OF A PROBLEM SOLVING EFFORT, HE FASTENED A SYRINGE OF SALINE TO THE SYSTEM AND WAS ABLE TO FLUSH THE IV, THOUGH HE REPORTED THAT THE EFFORT WAS GREATER THAN WOULD BE NORMAL FOR AN 18G IV CATHETER. HE ATTEMPTED AGAIN TO INFUSE THE BLOOD, BUT MET THE SAME RESISTANCE AS BEFORE". THE INVOLVED 12514-01 SET WAS REMOVED, REPLACED AND REPORTEDLY DISCARDED. THERE WERE NO REPORTED ADVERSE PT CONSEQUENCES. THE MFGER HAS MADE MULTIPLE REQUESTS FOR ADDITIONAL EVENT/USAGE INFO. AS OF THE DATE OF THIS REPORT THERE HAS BEEN NO RESPONSES. A TWO YEAR REVIEW OF THE COMPLAINT AND INVESTIGATION DATA FOR ALL IV SETS/SIMILAR FLOW ISSUES DID RECORD ADDITIONAL REPORTS. A REVIEW OF THOSE REPORTS/DEVICE RETURN INVESTIGATION IDENTIFIED MIXED FINDINGS INCLUDING NO DEFECT FOUND; USAGE/TECHNIQUE ERRORS; COMPONENT DAMAGES ATTRIBUTABLE TO USE OF INCOMPATIBLE MATING/ACCESS DEVICES AND CANNOT DETERMINE. THE DATABASE ANALYSIS IDENTIFIED NO ADVERSE TRENDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341758 7" PRESSURE INFUSION SET 7" PRESSURE INFUSION SET FPA ICU MEDICAL, INC. 12514-01 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NI 60 CC SYRINGE| UNKNOWN STOPCOCKS| 18G IV CATHETER