BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WARMER DRAPE

    MDR report key: 5443101 · Received February 17, 2016

    Report

    Report Number
    8043817-2016-00014
    Event Type
    Malfunction
    Date Received
    February 17, 2016
    Report Date
    December 7, 2015
    Manufacturer
    MICROTEK DOMINICANA, S.A.
    Product Code
    LHC
    PMA / PMN Number
    K142080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT D152501A, THIS LOT HAD 2,400 PCS AND IT WAS MANUFACTURED ON 09/08/15. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. BASED ON THE DHR REVIEW THE NON CONFORMITY DOES NOT APPEAR TO BE THE RESULT OF A PERSONNEL, PROCESS OR MATERIAL ISSUE. DUE TO RECEIVING NO SAMPLE THE NON CONFORMITY COULD NOT BE PHYSICALLY CONFIRMED. MELTS CAN OCCUR WHEN THE WARMER IS NOT DRAPED PROPERLY, NOT TURNED OFF BY USING THE POWER BUTTON, AND/OR THERE IS INSUFFICIENT FLUID IN THE WARMER BASIN, CONTRARY TO THE OPERATIONS MANUAL, PRODUCT LABELING, PRODUCT INSERT AND IN-SERVICE PRESENTATIONS.

    Additional Manufacturer Narrative · 1

    LOT D152501A, THIS LOT HAD (B)(4) AND IT WAS MANUFACTURED ON 09/08/15. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING, OR FINAL INSPECTION. BASED ON THE DHR REVIEW THE NON CONFORMITY DOES NOT APPEAR TO BE THE RESULT OF A PERSONNEL, PROCESS OR MATERIAL ISSUE. DUE TO RECEIVING NO SAMPLE THE NON CONFORMITY COULD NOT BE PHYSICALLY CONFIRMED. MELTS CAN OCCUR WHEN THE WARMER IS NOT DRAPED PROPERLY, NOT TURNED OFF BY USING THE POWER BUTTON, AND/OR THERE IS INSUFFICIENT FLUID IN THE WARMER BASIN, CONTRARY TO THE OPERATIONS MANUAL, PRODUCT LABELING, PRODUCT INSERT AND IN-SERVICE PRESENTATIONS. FOLLOW UP #1: LOT 1042426 WAS REPORTED FOR THIS COMPLAINT. THIS IS THE STERILE LOT FROM MEDICAL ACTION WHICH CORRESPONDS TO THE MICROTEK NON STERILE LOTS D152501, D151761, D152031. THE DHR WAS REVIEWED FOR LOT D152501. THIS LOT HAD (B)(4) AND IT WAS MANUFACTURED ON 09/08/15. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. THE DHR WAS REVIEWED FOR LOT D151761. THIS LOT HAD (B)(4) AND IT WAS MANUFACTURED ON 06/25/15. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING, OR FINAL INSPECTION. THE DHR WAS REVIEWED FOR LOT D152031. THIS LOT HAD (B)(4) AND IT WAS MANUFACTURED ON 07/23/15. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING, OR FINAL INSPECTION. BASED ON THE DEVICE HISTORY RECORD THE DRAPE WAS MANUFACTURED TO SPECIFICATIONS AND THE NON CONFORMITY DOES NOT APPEAR TO BE THE RESULT OF A MATERIAL ISSUE. THE NON CONFORMITY COULD NOT BE CONFIRMED BECAUSE A SAMPLE WAS NOT RETURNED.

    Additional Manufacturer Narrative · 1

    LOT D152501A, THIS LOT HAD 2400 PCS AND IT WAS MANUFACTURED ON 09/08/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING, OR FINAL INSPECTION. BASED ON THE DHR REVIEW THE NON CONFORMITY DOES NOT APPEAR TO BE THE RESULT OF A PERSONNEL, PROCESS OR MATERIAL ISSUE. DUE TO RECEIVING NO SAMPLE THE NON CONFORMITY COULD NOT BE PHYSICALLY CONFIRMED. MELTS CAN OCCUR WHEN THE WARMER IS NOT DRAPED PROPERLY, NOT TURNED OFF BY USING THE POWER BUTTON, AND/OR THERE IS INSUFFICIENT FLUID IN THE WARMER BASIN, CONTRARY TO THE OPERATIONS MANUAL, PRODUCT LABELING, PRODUCT INSERT AND IN-SERVICE PRESENTATIONS. FOLLOW UP #1: LOT 1042426 WAS REPORTED FOR THIS COMPLAINT. THIS IS THE STERILE LOT FROM MEDICAL ACTION WHICH CORRESPONDS TO THE MICROTEK NON STERILE LOTS D152501, D151761, D152031. THE DHR WAS REVIEWED FOR LOT D152501. THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 09/08/15. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. THE DHR WAS REVIEWED FOR LOT D151761. THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 06/25/15. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING, OR FINAL INSPECTION. THE DHR WAS REVIEWED FOR LOT D152031. THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 07/23/15. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING, OR FINAL INSPECTION. BASED ON THE DEVICE HISTORY RECORD THE DRAPE WAS MANUFACTURED TO SPECIFICATIONS AND THE NON CONFORMITY DOES NOT APPEAR TO BE THE RESULT OF A MATERIAL ISSUE. THE NON CONFORMITY COULD NOT BE CONFIRMED BECAUSE A SAMPLE WAS NOT RETURNED.

    Description of Event or Problem · 1

    THE FLUID WARMER HAD A VERY SMALL HOLE IN THE DRAPE THAT WAS NOT DETECTED UNTIL THE SURGERY WAS COMPLETED. THE WAS USED AS PER USUAL WITH NO METAL OR SHARP OBJECTS PLACED IN THE BASIN. AFTER REMOVING THE DRAPE FROM THE WARMER, FLUID WAS SEEN IN THE BASIN SUGGESTING THE HOLE. THIS WAS ORIGINALLY REPORTED TO US ON A PRODUCT CONCERN FORM FROM (B)(6).

    Description of Event or Problem · 1

    THE FLUID WARMER HAD A VERY SMALL HOLE IN THE DRAPE THAT WAS NOT DETECTED UNTIL THE SURGERY WAS COMPLETED. IT WAS USED AS PER USUAL WITH NO METAL OR SHARP OBJECTS PLACED IN THE BASIN. AFTER REMOVING THE DRAPE FROM THE WARMER, FLUID WAS SEEN IN THE BASIN SUGGESTING THE HOLE. THIS WAS ORIGINALLY REPORTED TO US ON A PRODUCT CONCERN FORM FROM PROVIDENCE HEALTH BC CANADA.

    Description of Event or Problem · 1

    THE FLUID WARMER HAD A VERY SMALL HOLE IN THE DRAPE THAT WAS NOT DETECTED UNTIL THE SURGERY WAS COMPLETED. IT WAS USED AS PER USUAL WITH NO METAL OR SHARP OBJECTS PLACED IN THE BASIN. AFTER REMOVING THE DRAPE FROM THE WARMER, FLUID WAS SEEN IN THE BASIN SUGGESTING THE HOLE. THIS WAS ORIGINALLY REPORTED TO US ON A PRODUCT CONCERN FORM FROM (B)(6) .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99234 WARMER DRAPE FLUID WARMING AND SLUSH DRAPES LHC MICROTEK DOMINICANA, S.A. ORS-100N SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1