BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTINU-FLO SOLN. SET, 3 LUERACTIVATED VALVES

    MDR report key: 1982216 · Received February 9, 2011

    Report

    Report Number
    6000001-2011-00752
    Event Type
    Injury
    Date Received
    February 9, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 24, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE CUSTOMER, THE SAMPLE WAS DISCARDED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF BAXTER'S INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE FOLLOWING INFORMATION WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE. A RISK MANAGEMENT REPRESENTATIVE WHO ALSO IDENTIFIED HERSELF AS AN ATTORNEY FOR (B)(6) HOSPITAL CALLED BACK FROM A MESSAGE THAT WAS LEFT FOR NURSING MANAGER. THE REPORTER STATED THAT SHE WOULD NOT DISCUSS ANYTHING RELATED TO THIS CASE. SHE DECLINED TO PROVIDED INFORMAITON ON WHETHER ANY MEDICATION WAS MIXED WITH THE D5 NORMAL SALINE. SHE DECLINED TO DISCUSS THE TREATMENT OUTCOME FOR THE EVENT. ALL INFORMATION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE FOR THE REPORT OF A LEAK WAS UNKNOWN. THE SAMPLE WAS NOT RETURNED FOR EVALUATION. A BATCH REVIEW WAS PERFORMED AND NO DEVIATIONS WERE FOUND DURING THE MANUFACTURE OF THE LOT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    A BAXTER SALES REPRESENTATIVE REPORTED A LEAK, WHICH OCCURRED DURING PATIENT USE. PER THE DIRECTOR OF NURSING, THE LEAK MAY HAVE CONTRIBUTED TO THE FALL OF AN UNKNOWN PATIENT. THE DRUG THAT WAS INFUSING WAS UNKNOWN. THE FOLLOWING INFORMATION WAS OBTAINED FROM THE NURSE MANAGER. PER THE NURSE MANAGER, THE SET WAS NOTED TO BE LEAKING DIRECTLY BELOW THE DRIP CHAMBER DURING PATIENT USE, WHICH RESULTED IN A PATIENT FALLING. THE INCIDENT OCCURRED ON (B)(6) 2011 AND AN INCIDENT REPORT WAS FILED. THE PATIENT HAD A BED CHECK IN PLACE, BUT IT DID NOT WORK. ON AN UNKNOWN DATE, THE PATIENT WAS TRANSFERRED TO ANOTHER FLOOR AND BEGAN COMPLAINING OF BACK PAIN. AN X-RAY WAS TAKEN AND THE PATIENT WAS FOUND TO HAVE A FRACTURED VERTEBRAE. THE PATIENT HAD A HISTORY OF FALLING AT HOME, BUT IT COULD NOT BE CONFIRMED IF THE FRACTURE WAS OLD AS NO FILMS WERE TAKEN PRIOR TO THE FALL. NO TREATMENT WAS REPORTED FOR THE FRACTURE. THE PATIENT'S MEDICAL HISTORY WAS UNKNOWN. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR A TRANSIENT ISCHEMIC ATTACK (TIA). THE PATIENT WAS DISCHARGED ON AN UNKNOWN DATE. THE SET WAS BEING USED WITH A FLOGARD PUMP (SERIAL NUMBER, MODEL NUMBER UNKNOWN) AND WAS INFUSING D5 NORMAL SALINE. THE PUMP DID NOT ALARM. THE TUBING WAS NEW AND HAD ONLY BEEN USED FOR THIS PARTICULAR INFUSION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTINU-FLO SOLN. SET, 3 LUERACTIVATED VALVES SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other FLOGARD INFUSION PUMP