BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTXF SYM CONVTP 3CLV

    MDR report key: 1980966 · Received November 22, 2010

    Report

    Report Number
    9615050-2010-00235
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    September 17, 2010
    Report Date
    October 4, 2010
    Manufacturer
    HOSPIRA COSTA RICA LTD
    Product Code
    FRN
    PMA / PMN Number
    K041550
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    ATTACHMENT: USER FACILITY VOLUNTARY MEDWATCH REPORT WAS RECEIVED ON 10/04/2010. (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE RPTR UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    USER FACILITY VOLUNTARY MEDWATCH RECEIVED FROM (B)(6) THAT STATED: "THE LIFESHIELD SYMBIQ PUMP 150ML BURETTE SET-HOSPIRA LIST NUMBER (B)(4) HAD A DEFECT. THE BAG SPIKE SEPARATED FROM THE TUBING AND THE ENTIRE CONTENTS OF A NEONATAL TPN WAS SPILLED. PT WENT WITHOUT TPN FOR AN ADDITIONAL 24 HOURS AS A RESULT." UPON FURTHER QUERY THE FOLLOWING INFO WAS PROVIDED THAT INDICATED A TUBING SEPARATION. THE TUBING SET WAS TO BE USED TO DELIVER TPN TO A NEONATE. IT WAS REPORTED THAT DURING PRIMING IN THE PHARMACY PRIOR TO PT USE, THE TUBING SEPARATED FROM THE PIERCING PIN AND THE TPN SPILLED. THE PHARMACIST THEN PREPARED A "SUBSTITUTE" THERAPY OF AN UNSPECIFIED DEXTROSE SOLUTION. AFTER AN UNSPECIFIED LENGTH OF TIME, THE UNSPECIFIED DEXTROSE SOLUTION WAS DELIVERED TO THE PT. THE CUSTOMER CONTACT REPORTED THAT UNSPECIFIED LABWORK WAS DRAWN THAT INDICATED THERE WAS NO CHANGE IN THE PT'S GLUCOSE OR ELECTROLYTES VALUES. ALTHOUGH THERE WAS THE POTENTIAL FOR SERIOUS INJURY, THERE WAS NO CHANGE IN THE PT'S CONDITION. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LTXF SYM CONVTP 3CLV 80FRN FRN HOSPIRA COSTA RICA LTD NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1