BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HLM TUBING SET W/SOFTLINE COATING

    MDR report key: 5597085 · Received April 22, 2016

    Report

    Report Number
    8010762-2016-00288
    Event Type
    Injury
    Date Received
    April 22, 2016
    Date of Event
    March 1, 2016
    Report Date
    April 21, 2017
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K082117
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN REQUESTED BUT NOT YET RETURNED. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. ADDITIONAL INFORMATION: THE PRODUCT MENTIONED UNDER SECTION D IS A VKMO AND THE INCLUDED AFFECTED COMPONENT HAS THE CONTRIBUTING DESIGN FUNCTION OF THE QUADROX-I WHICH IS REGISTERED UNDER 510(K): K082117.

    Additional Manufacturer Narrative · 1

    ATTEMPTS FOR THE SAMPLE TO BE RETURNED WERE MADE BUT THE SAMPLE WAS NOT RECEIVED AND THEREFORE IT WAS NOT POSSIBLE FOR A FULL INVESTIGATION TO BE PERFORMED. AN INVESTIGATION HOWEVER, WAS COMPLETED IN ANTALYA, TURKEY BASED UPON THE AVAILABLE INFORMATION. THE INVESTIGATION SHOWED THAT THE COMPLAINED LOT WAS A REWORK LOT, WITH THE REWORK RELATING TO DAMAGED BOXES, ONLY THE OUTER BOXES OF THE SET WERE CHANGED. IT COULD BE POSSIBLE THAT THE CLAIMED SET COULD HAVE BEEN REWORKED. THE INVESTIGATION DETERMINED THAT THE FAILURE WAS UNLIKELY TO HAVE OCCURRED DURING PRODUCTION AS THERE IS A 100% VISUAL CONTROL OF THE OXYGENATORS WITHIN THE PRODUCTION PROCESS. HOWEVER, THE OPERATORS WERE INFORMED ABOUT THE COMPLAINT AND INSTRUCTED TO BE MORE ATTENTIVE DURING THESE CONTROLS. THEREFORE, IT WAS CONCLUDED THAT THE MOST PROBABLE ROOT CAUSE OF THE FAILURE WAS DUE TO EXCESSIVE PHYSICAL FORCE OCCURRING DURING TRANSPORTATION. A DHR REVIEW OF LOT 92159714 WAS PERFORMED AND THE INVESTIGATION FOUND NO ABNORMALITIES AND ALL THE CONTROLS WERE COMPLETED IN ACCORDANCE WITH THE PROCESS CONTROL FORM. NO SYSTEMIC ISSUE WAS IDENTIFIED FROM THE COMPLAINT DATABASE REVIEW BUT THE DATA, HOWEVER, WILL CONTINUE TO BE MONITORED AND IF A TREND OCCURS, IT WILL BE ESCALATED TO QUALITY ASSURANCE MANAGEMENT FOR REVIEW AND DETERMINATION IF FURTHER INVESTIGATION IS NECESSARY. DUE TO THIS NO FURTHER INVESTIGATION OR ACTION IS WARRANTED AT THIS TIME AND THE COMPLAINT WILL BE CLOSED. PLEASE NOTE THIS IS THE FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT HAS BEEN ADDITIONALLY INVESTIGATED BY MAQUET (B)(4). THEREBY THE MOST PROBABLE CAUSE COULD BE DETERMINED AS EXCESSIVE PHYSICAL FORCE DURING TRANSPORT. THE REPORTED LOT WAS A REWORK LOT. THE REWORK WAS RELATED TO DAMAGED BOXES, ONLY THE OUTER BOXES OF THE SETS WERE CHANGED. THEREFORE IT COULD BE POSSIBLE THAT THE CLAIMED SET MAY HAVE BEEN REWORKED. A DEVICE HISTORY RECORD OF THE LOT HAS BEEN INVESTIGATED AND NO ABNORMALITY WAS FOUND. MOREOVER, NO SCRAP RECORD WAS FOUND FOR THE RELATED MATERIAL. ADDITIONALLY THERE WAS JUST ONE SET RELATED WITH THE FAILURE. THERE IS A 100% CONTROL INSTRUCTION RELATED WITH THE VISUAL CONTROLS OF THE OXYGENATORS DURING PRODUCTION. FURTHERMORE THE OPERATORS HAVE BEEN INSTRUCTED TO BE MORE CAREFUL DURING VISUAL CONTROLS OF THE OXYGENATORS. INVESTIGATION IS STILL PENDING. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED AS SOON AS FURTHER INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    CHANGED TO ADVERSE EVENT; REQUIRED INTERVENTION. TYPE OF EVENT -SERIOUS INJURY. INVESTIGATION IS STILL PENDING. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    LEAKAGE FROM LUER LOCK ON BLOOD INLET CONNECTOR. (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Description of Event or Problem · 1

    (B)(4)

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257407 HLM TUBING SET W/SOFTLINE COATING OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY AG VKMO 78000 92159714

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention