BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WARMER DRAPE

    MDR report key: 5414785 · Received February 6, 2016

    Report

    Report Number
    8043817-2016-00010
    Event Type
    Malfunction
    Date Received
    February 6, 2016
    Date of Event
    September 27, 2015
    Report Date
    January 6, 2016
    Manufacturer
    MICROTEK DOMINICANA, S.A.
    Product Code
    LHC
    PMA / PMN Number
    K142080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE FROM (B)(6) WAS RECEIVED ON 2/1/16 AND REVIEWED ON 2/2/16. THE SAMPLE DRAPE WAS SOAKED IN BLEACH WATER FOR ABOUT 1.5 HOURS, RINSED, LET DRY, EXAMINED AND PHOTOS TAKEN. CUSTOMER WASN'T SURE WHY LIQUID WAS IN BASIN. CHECKED OVER SAMPLE AND COULDN'T SEE ANY VISIBLE HOLES, BURNS OR TEARS. THEN PLACED WATER ON WARMER SIDE OF DRAPE. NOTICED A LEAK AND CIRCLED SPOT WITH BLUE MARKER. UPON FURTHER EXAMINATIO THE DRAPE HAD A SMALL 1/2 INCH CUT ABOUT 18 1/2 INCHES FROM THE SLUSH PLATE. THIS CUT APPEARS TO HAVE BEEN CREATED BY A SHARP OF SOME KIND OBJECT.

    Additional Manufacturer Narrative · 1

    SAMPLE FROM (B)(6) WAS RECEIVED ON 2/1/2016 AND REVIEWED ON 2/2016. THE SAMPLE DRAPE WAS SOAKED IN BLEACH WATER FOR ABOUT 1.5 HOURS, RINSED, LET DRY, EXAMINED AND PHOTOS TAKEN. CUSTOMER WASN'T SURE WHY LIQUID WAS IN THE BASIN. CHECKED OVER SAMPLE AND COULDN'T SEE ANY VISIBLE HOLES, BURNS OR TEARS. THEN PLACED WATER ON WARMER SIDE OF DRAPE. NOTICED A LEAK AND CIRCLED SPOT WITH BLUE MARKER. UPON FURTHER EXAMINATION THE DRAPE HAD A SMALL 1/2 INCH CUT ABOUT 18 1/2 INCHES FROM THE SLUSH PLATE. THIS CUT APPEARS TO HAVE BEEN CREATED BY A SHARP OBJECT OF SOME KIND. FOLLOW UP #1: LOT 1037253 WAS REPORTED FOR THIS COMPLAINT. THIS IS THE STERILE LOT FROM MEDICAL ACTION WHICH CORRESPONDS TO THE MICROTEK NON STERILE LOTS D1518181, D151611, D151941, D151331, D152221, D151451, D151381, D151391, D151351, D152161, D151601. THE DHR WAS REVIEWED FOR D151181. THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 04/28/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. THE DHR WAS REVIEWED FOR D151451. THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 05/25/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. THE DHR WAS REVIEWED FOR D151331. THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 05/13/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. THE DHR WAS REVIEWED FOR D151381. THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 05/19/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. THE DHR WAS REVIEWED FOR D151391. THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 05/20/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. THE DHR WAS REVIEWED FOR D151611. THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 06/10/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. THE DHR WAS REVIEWED FOR D151941. THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 07/14/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. THE DHR WAS REVIEWED FOR D151351. THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 05/18/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. THE DHR WAS REVIEWED FOR D152161. THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 08/05/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. THE DHR WAS REVIEWED FOR D152221. THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 08/11/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. THE DHR WAS REVIEWED FOR D151501. THIS LOT WAS NOT ASSIGNED FOR PRODUCTS ORS-320 / ORS-320N. BASED ON THE DHR AND SAMPLE REVIEW, THE NON CONFORMITY APPEARS TO BE THE RESULT OF A SHARP OBJECT THAT WAS PLACED IN THE BASIN. IT DOES NOT APPEAR TO BE THE RESULT OF A PERSONNEL, PROCESS OR MATERIAL ISSUE.

    Description of Event or Problem · 1

    AFTER THE SURGERY WAS OVER AND THE PATIENT HAD LEFT THE OPERATING ROOM, THE DRAPES WERE BEING DISPOSED FROM THE SLUSH/WARMER. AN END USER NOTICED THAT THERE WAS 20-30ML OF FLUID IN THE BOTTOM OF THE WARMER WHICH SHOULD NOT HAVE BEEN THERE. IT IS UNKNOWN HOW THE FLUID GOT THERE. THERE WERE NO PATIENT INJURY AND TREATMENT REPORTED OF THE INCIDENT.

    Description of Event or Problem · 1

    AFTER THE SURGERY WAS OVER AND THE PATIENT HAD LEFT THE OR, THE DRAPES WERE BEING DISPOSED OF. WHEN THE DRAPE WAS REMOVED FROM THE SLUSH/WARMER MACHINE, THERE WAS 20-30 ML OF FLUID NOTED IN THE BOTTOM OF THE WARMER WHICH SHOULD NOT HAVE BEEN THERE. IT IS UNKNOWN HOW THE FLUID GOT THERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73390 WARMER DRAPE FLUID WARMING AND SLUSH DRAPES LHC MICROTEK DOMINICANA, S.A. ORS-320N SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR