BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HLS CANNULA + PIK

    MDR report key: 20744916 · Received November 21, 2024

    Report

    Report Number
    8010762-2024-0000549
    Event Type
    Malfunction
    Date Received
    November 21, 2024
    Date of Event
    October 29, 2024
    Report Date
    November 20, 2024
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DWF
    UDI-DI
    04037691519876
    PMA / PMN Number
    K131666
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE BENT DETECTED (METAL SPIKED) ON GUIDE WIRE. CUSTOMER FEELS RESISTANCE WHEN INSERTING THE GUIDEWIRE TO THE BLOOD VESSEL, AND IT WAS DECIDED TO REMOVE THE GUIDE WIRE. THE SPIKE WAS FOUND AFTER WITHDRAWAL. PRODUCT WAS REPLACED DURING TREATMENT. NO HARM OR DEATH TO ANY PERSON WAS REPORTED. MORE INFORMATION WAS RECEIVED BY GETINGE SALES & SERVICE REPRESENTATIVE: THE GUIDEWIRE WAS VISUALLY CHECKED BEFORE USE ACCORDING TO IFU. THE USER FELT RESISTANCE DURING INSERTION. THE GUIDEWIRE WAS NOT REMOVED WHEN THE NEEDLE WAS PLACED INTO PATIENT¿S VESSEL. NO DEFECT OBSERVED ON OUTER PACKAGING OF PIK. BASED ON THE PHOTOGRAPHICAL EVIDENCE PROVIDED, COMPLAINT COULD BE CONFIRMED. THE REPORTED FAILURE COULD BE LINKED TO THE RISK ASSESSMENT FILE OF THE PRODUCT AND POSSIBLE CAUSES ARE; USER: APPLICATION OF DAMAGED PRODUCT, USER ERROR: USER DOES NOT REMOVE THE PUNCTURE NEEDLE BEFORE THE GUIDEWIRE IS RETRACTED FOR REPOSITIONING, MANUFACTURING: MATERIALS, COMPONENTS OR DEVICE COMPROMISED DURING PRODUCTION, MATERIAL: USE OF UNQUALIFIED MATERIALS. HOWEVER, ACCORDING TO THE CORRESPONDING INCOMING INSPECTION REPORTS, ALL TESTS WERE PASSED AS PER SPECIFICATIONS. FURTHER, THE NON-CONFORMITY RECORD REVIEW WAS PERFORMED FOR THE RELATED COMPONENTS, AND THERE COULD NOT BE FOUND ANY RELATED NC RECORD AND CORRESPONDING BOPS ARE IN PLACE AND COVERS THE VISUAL CONTROL POINTS. BASED ON THE PROVIDED THE MANUFACTURING DOCUMENTATION BY SUPPLIER, MATERIAL RELATED INFLUENCES ARE UNLIKELY. THE MOST PROBABLE ROOT CAUSE IS LINKED TO USER MISHANDLING DURING INSERTION OR RETRACTION OF THE GUIDEWIRE THROUGH THE NEEDLE TIP. THESE ROOT CAUSES COULD NOT BE CONFIRMED. THE PRODUCTION HISTORY RECORD (DHR) OF THE AFFECTED PIK 150#INSERTION KIT WITH LOT# 3000379858 WAS REVIEWED ON 2024-11-13. ACCORDING TO THE DHR RESULT, THE PRODUCT PIK 150#INSERTION KIT PASSED THE DEFINED MANUFACTURING AND FINAL RELEASE SPECIFICATIONS. THE CORRESPONDING COMPONENT GUIDEWIRE PASSED ALL MECHANICAL (TENSILE) AND DIMENSIONAL MEASUREMENTS (E.G DIAMETER AND VISUAL INSPECTIONS) WITHOUT DEVIATIONS. FURTHER, THE NON-CONFORMITY RECORD REVIEW WAS PERFORMED FOR THE RELATED COMPONENTS, AND THERE COULD NOT BE FOUND ANY NON-CONFORMITY RECORD RELATED TO THE CONSUMED BATCH OF GUIDEWIRE WITHIN THE REPORTED FINISH PRODUCT IN COMPLAINT. BESIDES, BASIC OPERATION PROCEDURES INCLUDE 100% VISUAL INSPECTION OF THE COMPONENT UNDER 2.5X.¿ REVIEW OF THE DEVICE HISTORY RECORD SHOWS THAT ALL RELATED CONTROLS WERE PASSED, AND THE COMPONENT IS COMPLIED WITH SPECIFICATIONS. BASED ON THESE, MATERIAL RELATED INFLUENCES ARE UNLIKELY. IFU, PIK, G-137, GLOBAL, PAGE 11 ¿APPLICATION¿ DAMAGE TO THE DEVICE OR PACKAGING. A NON-STERILE OR DEFECTIVE DEVICE CAN RESULT IN PATIENT INFECTIONS. PERFORM A CAREFUL VISUAL INSPECTION OF THE STERILE PACKAGING BEFORE USE. PAY PARTICULAR ATTENTION TO MOISTURE, OPENINGS AND SOILING. PERFORM A CAREFUL VISUAL INSPECTION OF THE DEVICE BEFORE USE. IN PARTICULAR, ENSURE THERE IS NO DAMAGE TO THE MATERIAL, CRACKS, BURRS OR FISSURES. CAUTION! BEFORE HANDLING IT MUST BE ENSURED THAT THE PUNCTURE NEEDLE AND SCALPEL ARE FITTED WITH PROTECTIVE CAPS. CAUTION! TO PREVENT THE GUIDE WIRE FROM BEING DAMAGED, DO NOT RETRACT IT WHILST THE PUNCTURE NEEDLE IS IN THE VESSEL. 6 IF THE GUIDE WIRE HAS TO BE REMOVED AGAIN, FIRSTLY REMOVE THE PUNCTURE NEEDLE FROM THE VESSEL, AND THEN CAREFULLY REMOVE THE GUIDE WIRE. 7 ADVANCE THE GUIDE WIRE UNTIL IT IS LOCATED AT THE DESIRED CANNULA TIP POSITION. 8 HOLD THE GUIDE WIRE AT THE EXIT SITE AND REMOVE THE PUNCTURE NEEDLE FROM THE VESSEL. REMOVE THE PUNCTURE NEEDLE ALONG THE GUIDE WIRE. 9 ENLARGE THE PUNCTURE SITE SLIGHTLY WITH THE SCALPEL. THE OCCURRENCE RATE WAS CALCULATED FOR THE REPORTED FAILURE AND PRODUCT, AND IT WAS DETERMINED THAT THIS IS NOT A SYSTEMIC ISSUE. THEREFORE, NO REMEDIAL ACTION IS REQUIRED. THE OCCURRENCE RATE RELATED TO THE REPORTED ISSUE IS CURRENTLY BEING MONITORED AS PART OF MAQUET CARDIOPULMONARY¿S TRENDING PROGRAM AND ADDITIONAL INVESTIGATIONS OR CORRECTIONS WILL BE IMPLEMENTED IN CASE OF ADVERSE TRENDING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BENT DETECTED (METAL SPIKED) ON GUIDE WIRE. PRODUCT WAS REPLACED. NO HARM OR DEATH TO ANY PERSON WAS REPORTED. COMPLAINT #(B)(4).

    Description of Event or Problem · 0

    COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2432799 HLS CANNULA + PIK CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF MAQUET CARDIOPULMONARY GMBH PIK 150#INSERTION KIT, GUIDEWIRE 150 CM 3000379858 04037691519876

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other