BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIFURCATED EXTENSION SET

    MDR report key: 3831974 · Received March 7, 2014

    Report

    Report Number
    3007056120-2014-00010
    Event Type
    Malfunction
    Date Received
    March 7, 2014
    Report Date
    February 7, 2014
    Manufacturer
    PHILIPS RESPIRONICS - CHMV
    Product Code
    FPA
    PMA / PMN Number
    001872
    Removal / Correction Number
    NO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE TRIFURCATED EXTENSION SET WAS DEVELOPED FOR USE WITH BOTH VOLUMETRIC AND SYRINGE PUMPS IN RESPONSE TO THE CLINICAL CHALLENGE OF LIMITED IV ACCESS IN CRITICALLY-ILL INFANTS. IT OFFERS CONVENIENCE AND FLEXIBILITY BY ALLOWING CAREGIVERS TO ADMINISTER UP TO THREE FLUIDS. IT IS IDEAL FOR SPECIALTY APPLICATIONS INCLUDING CARDIAC MEDICATIONS, MULTIPLE ANTIBIOTICS, PRE-AND POST-OP MEDICATIONS AND CONTINUOUS INSULIN INFUSION. THE TRIFURCATED EXTENSION SET IS MANUFACTURED BY CODAN U.S. CORPORATION AND DISTRIBUTED BY (B)(4). BASED ON A COMPLETE REVIEW OF THE AVAILABLE INFORMATION IT IS CONCLUDED THAT THE COMPLAINT ALLEGATION COULD NOT BE SUBSTANTIATED. IF THE UNIT IS RETURNED FOR INVESTIGATION OR IF FURTHER INFORMATION IS RECEIVED, AN ADDITIONAL INFORMATION, FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    CHILDREN'S MEDICAL VENTURES (CHMV) RECEIVED A CUSTOMER COMPLAINT ALLEGATION ASSOCIATED WITH THE TRIFURCATED EXTENSION SET PRODUCT. THE CUSTOMER STATED THAT THEY "ARE JUST PLAIN BREAKING." THERE IS NO ALLEGATION OF PATIENT HARM. THE EXACT PRODUCT ISSUE THE CUSTOMER IS EXPERIENCING IS UNKNOWN. THE CUSTOMER HAS BEEN CONTACTED FOR ADDITIONAL INFORMATION AND THE RETURN OF THE DEVICE. HOWEVER, NO RESPONSE HAS BEEN RECEIVED AND THE DEVICE HAS NOT BEEN RETURNED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139067 TRIFURCATED EXTENSION SET FPA PHILIPS RESPIRONICS - CHMV 92062-1100 11629 AND 11911

    Patients

    Seq Age Sex Outcome Treatment
    1