BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUTLOOK SAFETY INFUSION SYSTEM PUMP SETS

    MDR report key: 4360370 · Received December 16, 2014

    Report

    Report Number
    9614279-2014-00050
    Event Type
    Malfunction
    Date Received
    December 16, 2014
    Date of Event
    October 16, 2014
    Report Date
    November 18, 2014
    Manufacturer
    B. BRAUN OF DOMINICAN REPUBLIC
    Product Code
    FRN
    PMA / PMN Number
    K904518
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT # (B)(4). TWO USED OUTLOOK PUMP IV SETS, WITHOUT PACKAGING, WERE RECEIVED FOR EVAL. THE SETS WERE RECEIVED ATTACHED TO IV BAGS AND PIGGYBACKED TO A SECONDARY TUBING SET. THE SETS WERE SUBJECTED TO AN AIR PRESSURE (LEAKAGE) TEST ACCORDING TO SPECIFICATION WITH ACCEPTABLE RESULTS. THE SETS WERE THEN RE-TESTED, WITH THE ADDITIONAL CONDITION OF CLOSING THE ROLLER CLAMP DURING TESTING. DURING THIS TEST, THE ROLLER CLAMP FUNCTIONED PROPERLY AND NO LEAKAGE OR FREE FLOW WAS OBSERVED. IN AN ATTEMPT TO SIMULATE THE REPORTED INCIDENT, THE SECONDARY SETS WERE CONNECTED TO A BAG FILLED WITH A BLUE DYE SOLUTION AND THEN PIGGYBACKED INTO THE PRIMARY SETS. NO FREE FLOW WAS OBSERVED DURING THIS TEST, HOWEVER THE BLUE DYE SOLUTION BEGAN TO RUN PAST THE BACKCHECK VALVE AND UP THE PRIMARY LINE ON THE FIRST SET. NO ISSUES OR ANOMALIES WERE IDENTIFIED WITH THE SECOND SET. SINCE THE BACKCHECK VALVE ALLOWED THE SECONDARY SOLUTION TO RUN UP THE PRIMARY LINE, THIS COULD POTENTIALLY GIVE THE APPEARANCE OF THE SECONDARY SOLUTION EMPTYING SOONER THAN EXPECTED. HOWEVER, THE SECONDARY SOLUTION WAS GOING INTO THE PRIMARY DRIP CHAMBER AND NOT FREE FLOWING. THIS REPORT EVENT IS BEING FURTHER INVESTIGATED IN CONJUNCTION WITH THE INVOLVED OUTLOOK PUMPS (IDENTIFIED AS MFG REPORT 31641965-2014-00030 (B. BRAUN MEDICAL INC. INTERNAL REPORT # (B)(4)) AND MFG REPORT # 164965-2014-00031 (B. BRAUN MEDICAL INC. INTERNAL REPORT # (B)(4))). WITHOUT THE INVOLVED TUBING SET LOT NUMBER, A THOROUGH EVAL COULD NOT BE PERFORMED. IF ADDITIONAL PERTINENT INFO BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: EVENT # 1: REPORTS THERE WERE TWO INCIDENTS OF OVER-INFUSION WITH THE OUTLOOK 400ES PUMP. THE PRIMARY TUBING THAT WAS USED IN EACH INCIDENT WAS US3130. THE REPORTER STATED THAT PERHAPS IT WAS A FAILURE OF THE BACKCHECK VALVE IN THE SET, AND NOT NECESSARILY A PUMP OVER-INFUSION. THE PIGGYBACK SOLUTION MAY HAVE BACKED UP THE PRIMARY TUBING, OVERRIDING THE BACKCHECK VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826325 OUTLOOK SAFETY INFUSION SYSTEM PUMP SETS OUTLOOK PUMP SET WITH ULTRASITE FRN B. BRAUN OF DOMINICAN REPUBLIC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK OUTLOOK 400ES PUMP (CATALOG# 621-400ES)