BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULA & CATHETER

    MDR report key: 10974194 · Received December 9, 2020

    Report

    Report Number
    8010762-2020-00427
    Event Type
    Malfunction
    Date Received
    December 9, 2020
    Date of Event
    November 28, 2020
    Report Date
    December 15, 2020
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DWF
    PMA / PMN Number
    K102532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT BE-PVL 2355 HLS CANNULA WAS DIRECTLY INVOLVED IN THE INCIDENT WHICH OCCURRED DURING CANNULATION. IT WAS REPORTED THAT A HANDLE OF THE INTRODUCER FELL OFF. PHOTOGRAPH SHOWING THE FAILURE WAS PROVIDED AND ATTACHED TO PARENT RECORD. GETINGE CP ANTALYA DECIDED NOT TO INVESTIGATE THE SAMPLE DUE TO THE FACT THAT THE FAILURE IS KNOWN AND SIMILAR PRODUCT SHOWING A SIMILAR MALFUNCTION WAS ALREADY INVESTIGATED IN COMPLAINT 255626. THE FAILURE COULD BE CONFIRMED. FURTHERMORE THERE IS CAPA (CORRECTIVE AND PREVENTIVE ACTION) FOR THIS PRODUCT AND FAILURE. DEVICE HISTORY RECORD FOR LOT 92287768 WAS REVIEWED. THERE ARE NO EVIDENCES INDICATING NON-CONFORMANCE OR DEVIATIONS OF THE PRODUCT IN QUESTION DURING MANUFACTURING AND FINAL RELEASE OF THIS SPECIFIC LOT. THE REPORTED FAILURE IS IDENTIFIED AS A PART OF CURRENT RISK MANAGEMENT FILE DMS #1992719 V04 CHAPTERS H1.2.9, H2.2.15. THE MITIGATION FOR THIS SPECIFIC FAILURE IS IN PLACE PER DESIGN SPECIFICATION. FUTHERMORE, THIS LOT NUMBER HAS BEEN CONTROLLED 100% ACCORDING TO SI-B-289 REV0 WITH AN EQUIPMENT WHICH CREATES 19,64 ± 2,00 N VERTICAL FORCE ON GRIP. GETINGE CP ANTALYA INITIATED CAPA 296548 BASED ON SEVERAL COMPLAINTS SHOWING THE SAME SYMPTOMS WITH DIFFERENT MATERIAL NUMBERS THAN THE ONE IN THIS COMPLAINT, IN ORDER TO DETERMINE THE ROOT CAUSE AND INITIATE FURTHER ACTIONS TO DETERMINE CORRECTIVE MEASURES FOR THE FAILURE. CAPA WAS INITIATED ON 2020-02-24. CAPA ROOT CAUSE INVESTIGATION HAS BEEN DONE WITH 6M METHOD ON 2020-04-30. IT WAS CONCLUDED IN THE INVESTIGATION REPORT OF THIS CAPA: "WHEN THE PROCESS AND PROCESS INPUTS ARE EVALUATED TOGETHER WITH THE LITERATURE, STUDIES ARE CARRIED OUT TO DETERMINE THE PROCESS PARAMETERS THAT CAN STABILIZE THE PROCESS. WITH THE STUDY, IT WAS AIMED TO BOTH DETERMINE THE CAUSES OF THE TYPE OF ADHESIVE FAILURE AND TO REVEAL THE PARAMETERS THAT CAN BE VALIDATED IN VALIDATION STAGES. IT IS A SENSITIVE PROCESS WHEN THE PROCESS IS EVALUATED TOGETHER WITH THE ADHESIVE AND GLUED "HARD TO BOND" MATERIAL. THE PROCESS IS CARRIED OUT MANUALLY WITH THE CURRENT BOP. AS A RESULT; THERE ARE DETERMINED 3 ROOT CAUSES AS BELOW; RC1: BOP IS NOT SUFFICIENT IN TERMS OF THE GLUING METHOD AND TENSILE TEST METHOD. RC2: PRA IS NOT SUFFICIENT IN TERMS OF ADHESION INTEGRITY FAILURE. RC3: VALIDATION OF BOP 9204421 REV03 IS NOT SUFFICIENT SINCE PARAMETERS ARE NOT DETERMINED/DEFINED EXACTLY. IN ORDER TO ELIMINATE THESE ROOT CAUSES, ACTIONS WILL BE DETERMINED IN THE ACTION PLAN SECTION OF THIS CAPA.". . THIS COMPLAINED PRODUCT WAS MANUFACTURED BEFORE THE ALL CORRECTIVE ACTIONS ARE IMPLEMENTED IN CAPA 296548. THIS COMPLAINT IS BEING MONITORED AS PART OF THE COMPLAINT DATA TRENDING OF MAQUET CARDIOPULMONARY AND FURTHER INVESTIGATIONS AND MEASURES WILL BE CONDUCTED IN CASE OF ADVERSE TRENDING.

    Description of Event or Problem · 0

    COMPLAINT: #(B)(4).

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    "FOR ECMO PROCEDURE, HLS CANNULAE WAS INSERTED INTO THE PATIENT. WHILE THE WHITE WICK WAS PULLED OUT, THE HANDLE FELL OFF. AND THE CUSTOMER DECIDED TO REMOVE THE CANNULAE. THE PROCEDURE WAS COMPLETED WITH A NEW HLS CANNULAE." THE HANDLE AT THE END OF INTRODUCER FELL OF IN HLS CANNULAE SET, DURING INSERTION OF CANNULA. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1444677 CANNULA & CATHETER CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF MAQUET CARDIOPULMONARY GMBH 70104.7295 92287768

    Patients

    Seq Age Sex Outcome Treatment
    1