BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP

    MDR report key: 3025325 · Received March 20, 2013

    Report

    Report Number
    9615050-2013-00439
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    January 1, 2013
    Report Date
    February 25, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K982159
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACT INDICATED THE DEVICES WERE DISCARDED. HOSPIRA HAS COMPLETED A FORMAL INVESTIGATION TO ADDRESS THE ISSUE OF DEVICE BREAKAGE OF THE CLAVE SECONDARY PORT. BASED ON THE INVESTIGATION RESULTS, IT WAS DETERMINED THAT THE DEVICE BREAKAGE WAS DUE TO THE DESIGN OF CLAVE PORT THAT IS DIRECTLY BONDED TO THE SECONDARY PORT OF THE CASSETTE. (JGG). THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    GENERAL REPORT RECEIVED OF AN UNSPECIFIED NUMBER OF UNDOCUMENTED INCIDENTS OF CRACKS OF SEMI-RIGID ADAPTER; SUBSEQUENTLY, LEAKS WERE NOTED. ON UNSPECIFIED DATES, THE PRIMARY TUBING SETS WERE BEING USED TO DELIVER UNSPECIFIED MEDICATIONS, AT UNSPECIFIED RATES, VIA PLUM PUMPS. AT UNSPECIFIED TIMES, THE MALE ADAPTERS OF UNSPECIFIED SECONDARY TUBING SETS WERE CONNECTED TO THE CLAVE SECONDARY PORTS OF THE PRIMARY TUBING SETS FOR PIGGYBACK DELIVERIES OF UNSPECIFIED "ANTI-INFECTIVES." IT WAS REPORTED THAT AFTER THE SECONDARY TUBING SETS WERE CONNECTED TO THE CLAVE SECONDARY PORTS, UNSPECIFIED VOLUMES OF SOLUTIONS LEAKED AT THE CONNECTIONS OF THE SEMI-RIGID FEMALE ADAPTERS AND THE CASSETTES OF THE PRIMARY TUBING SETS. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAYS IN THERAPY CRITICAL TO THESE PATIENTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THE CUSTOMER CONTACT REPORTED THAT VISUAL EXAMINATIONS OF THE PRIMARY TUBING SETS FOUND THE SEMI-RIGID FEMALE ADAPTERS OF THE CLAVE SECONDARY PORTS ON THE CASSETTES OF THE PRIMARY TUBING SETS WERE CRACKED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115766 PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP 80 FRN HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK UNSPECIFIED SECONDARY TUBING SETS, MFR UNK