BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK DUO-VENT C-FLO SET10 DPM DUO-VENT

    MDR report key: 1960845 · Received January 14, 2011

    Report

    Report Number
    6000001-2011-00269
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 28, 2010
    Report Date
    December 29, 2010
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION / CORRECTIONS: THE SET INVOLVED IN THIS EVENT IS A CLEARLINK CONTINU-FLO SOLUTION SET AND THE DRUG INVOLVED IN THIS EVENT IS LACTATED RINGERS. THE BRAND NAME OF HIS SET IS - CLEARLINK DUO-VENT C-FLO SET10 DPM DUO-VENT. PRODUCT CODE - FPA. COMMON DEVICE NAME - SET, ADMINISTRATION, INTRAVASCULAR. MANUFACTURER NAME - BAXTER HEALTHCARE (B)(4). CATALOG NUMBER - 2C8541. THE SAMPLE WAS RECEIVED FOR EVALUATION ON 01/25/2011. THE DRUG INVOLVED IN THIS EVENT IS LACTATED RINGERS. MANUFACTURING SITE FACILITY NAME - BAXTER HEALTHCARE (B)(4). THE FDA 510K NUMBER FOR THIS SET IS K961225. AN ACTUAL SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION OF THE SAMPLE REVEALED THE TUBING WAS SEPARATED FROM THE DRIP CHAMBER. THE REPORTED CONDITION WAS CONFIRMED. ALTHOUGH THE REPORTED CONDITION WAS CONFIRMED, THE ROOT CAUSE WAS NOT IDENTIFIED. A BATCH REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER A CLEARLINK CONTINU-FLO SOLUTION SET THAT "CAME APART AT THE DRIP CHAMBER" AND SPILLED LACTATED RINGERS SOLUTION ONTO THE PATIENT. ACCORDING TO THE REPORT, THE EVENT OCCURRED PRIOR TO SURGERY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. THE REPORTER STATED THAT THE FACILITY'S BAXTER SALES REPRESENTATIVE CAME TO THE FACILITY FOR AN INSERVICE TRAINING; EXAMINED THE SET AND STATED THAT THERE IS A PROBLEM WITH THE PRODUCT AND THAT THE PROBLEM IS NOT THE RESULT OF A USE/USER ERROR. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER AN UNSPECIFIED IV SET THAT "CAME APART AT THE DRIP CHAMBER" AND SPILLED AN UNSPECIFIED SOLUTION ONTO THE PATIENT. ACCORDING TO THE REPORT, THE EVENT OCCURRED PRIOR TO SURGERY. THE REPORTER STATED IT WAS PROBABLY EITHER NORMAL SALINE OR D5W BUT COULD NOT CONFIRM. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. THE REPORTER STATED THAT THE FACILITY'S BAXTER SALES REPRESENTATIVE CAME TO THE FACILITY FOR AN INSERVICE TRAINING; EXAMINED THE SET AND STATED THAT THERE IS A PROBLEM WITH THE PRODUCT AND THAT THE PROBLEM IS NOT THE RESULT OF A USE/USER ERROR. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEARLINK DUO-VENT C-FLO SET10 DPM DUO-VENT SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1