BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUTLOOK

    MDR report key: 11782821 · Received May 6, 2021

    Report

    Report Number
    1641965-2021-00007
    Event Type
    Malfunction
    Date Received
    May 6, 2021
    Report Date
    September 28, 2021
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    FRN
    UDI-DI
    04046964186547
    PMA / PMN Number
    K011975
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). THE DEVICE INVOLVED WAS RECEIVED FOR EVALUATION. THERMAL TRACING SHOWS THE EVENT SOURCE AS INTERNAL TO THE PLUG OF THE AC POWER CORD (E30608) WITH THE RESULTANT HEAT/RESIDUE SPREADING OUT FROM THE PLUG TO THE DAISY CHAIN OUTLET AND INTO THE PUMP ITSELF (E36935) AND ONTO THE HOUSING OF E26027. THE EVENT SOURCE IS SEEN IN THE CAVITY THAT WAS FORMED BETWEEN THE CONTACTS OF THE AC POWER CORD. THE PLUG OF THE AC POWER CORD REMAINED SHORTED UNDER LOAD DURING TESTING. THE FOLLOWING IS A SUMMARY OF THE INFORMATION PROVIDED BY OUR ENGINEERING TEAM REGARDING THE PUMP'S FLAMMABILITY RATING INFORMATION: THE DEVICE MATERIAL IS CONFIRMING WITH CLAUSE 55DV.4.1 OF STANDARD 60601-1 FOR FLAMMABILITY RATING. NO ADDITIONAL TESTING WAS NEEDED ON THE PLASTIC ENCLOSURES AS THE MATERIAL AND MOLDER ARE APPROVED FOR THESE REQUIREMENTS. MATERIAL IS BAYBLEND FR-110 AS PER OUR SPECIFICATIONS. THIS MATERIAL IS LISTED WITH A UL94 FLAME RATING OF 5VB FOR 0.79" (2MM) THICK (BURNING STOPS WITHIN 60 SECONDS ON A VERTICAL SPECIMEN; NO DRIPS ALLOWED; PLAQUE SPECIMENS MAY DEVELOP A HOLE) AND 5VA FOR .118" (3MM) THICK. (BURNING STOPS WITHIN 60 SECONDS ON A VERTICAL SPECIMEN; NO DRIPS ALLOWED; PLAQUE SPECIMENS MAY NOT DEVELOP A HOLE). IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). THE DEVICE INVOLVED HAS NOT BEEN RECEIVED FOR EVALUATION AND THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

    Description of Event or Problem · 1

    AS PER REPORTED BY THE USER FACILITY: PUMP BEGAN TO SMOKE AND THERE WAS BLACK CHARRING AROUND THE OUTLET. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683676 OUTLOOK PUMP, INFUSION FRN B. BRAUN MEDICAL INC. 621-400ES 04046964186547

    Patients

    Seq Age Sex Outcome Treatment
    1