BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMARY PLUMSET 2 CLAVES 27 CM NDEHP

    MDR report key: 3931394 · Received June 26, 2014

    Report

    Report Number
    9615050-2014-04177
    Event Type
    Injury
    Date Received
    June 26, 2014
    Date of Event
    May 1, 2014
    Report Date
    June 5, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT COMPLETE. THE CATALOG NUMBER PROVIDED IS THE INTERNATIONAL LIST NUMBER THAT WAS INVOLVED IN THE REPORTED EVENT, WHICH IS COMPARABLE TO THE DOMESTIC LIST NUMBER. THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF (B)(4) AND HAS A 510K OF K982159. THE REPORTER WAS CONTACTED AND INFORMATION ON REPROCESSING OF THE DEVICE WAS REQUESTED; HOWEVER, THE INFORMATION WAS NOT OBTAINED. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED BACKFLOW OF FLUID. IT WAS REPORTED THAT THE PATIENT WAS INTRAOPERATIVE FOR A C-SECTION IN THE LABOR AND DELIVERY DEPARTMENT. THE CUSTOMER CONTACT REPORTED THAT THE PLUMSET WAS BEING USED TO DELIVER AN UNSPECIFIED CONCENTRATION OF SYNTOCINON, AT A RATE OF 120 ML/HR, VIA AN UNSPECIFIED PLUM PUMP. AT AN UNSPECIFIED TIME, AN UNSPECIFIED DEVICE WAS CONNECTED TO THE DISTAL CLAVE Y-SITE OF THE PLUMSET FOR THE PIGGYBACK DELIVERY OF 1 L OF HARTMANN'S SOLUTION, VIA GRAVITY. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED THAT THE SYNTOCINON WAS BEING FORCED UP INTO THE HARTMANNS SOLUTION CONTAINER AND WAS NOT BEING DELIVERED TO THE PATIENT. THE CUSTOMER CONTACT REPORTED THAT THE BLEEDING CONTINUED, THE UTERUS WAS NOT CONTRACTING, AND THE PATIENT REQUIRED EXTENDED SURGERY TO STOP THE BLEEDING. AT UNSPECIFIED TIMES, IT WAS REPORTED THAT 6 UNITS OF UNSPECIFIED BLOOD PRODUCT WERE DELIVERED TO THE PATIENT. THE CUSTOMER CONTACT INDICATED THAT AN ANTI-REFLUX VALVE DEVICE WAS NOT IN PLACE AS PER THE USUAL PRACTICE. AT AN UNSPECIFIED TIME WHEN THE PATIENT WAS TRANSFERRED TO THE WARD, IT WAS REPORTED THAT THE NURSES NOTED THAT THE LINE WAS NOT WORKING. IT WAS REPORTED THAT A THREE WAY TAP WAS IN PLACE WITH IV THERAPY BEING GIVEN THAT ROUTE AND IT APPEARED THAT THE LINE WAS BLOCKED AND NOT WORKING AND THAT IS WHY THERAPY DID NOT GET THROUGH TO THE PATIENT. NO SPECIFIC DETAILS WERE PROVIDED. THE CUSTOMER CONTACT INDICATED THAT THE PATIENT MADE A FULL RECOVERY AND THERE WAS NO ADVERSE OUTCOME REPORTED FOR THE INFANT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372917 PRIMARY PLUMSET 2 CLAVES 27 CM NDEHP UNK FRN HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Life Threatening| R UNSPECIFIED DEVICE: MFR UNK