BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    72" VENTED MACRO DR

    MDR report key: 398601 · Received June 5, 2002

    Report

    Report Number
    398601
    Event Type
    Malfunction
    Date Received
    June 5, 2002
    Date of Event
    February 1, 2002
    Report Date
    June 3, 2002
    Manufacturer
    DEROYAL
    Product Code
    LRO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 8/27/02: THE MANUFACTURING LOT NUMBER(S) OF THE KITS CONTAINING THE 72" VENTED MACRO DR (5-12886), TRANSDUCER (5-000112), LT HEART KIT (77-400305) AND BAG (5-300752) WERE NOT PROVIDED BY CUSTOMER ON ANY OF THE COMPLAINTS REPORTED. CUSTOMER'S COMPLAINTS COULD NOT BE TRACKED TO SPECIFIC DEVICE HISTORY RECORDS. REVIEWS OF ALL DEVICE HISTORY RECRODS FOR FINISHED GOOD NUMBER 77-400305 (LEFT HEART KIT) WERE PERFORMED. DEROYAL RESPONSE: LABORATORY TESTS WERE NOT PERFORMED. DEROYAL EXPECTED A SAMPLE DEFECT RETURN FOR TRANSDUCERS CUSTOMER REPORTED AS MALFUNCTIONING WOULD BE MADE AVAILABLE TO THEM. ATTEMPTS WERE MADE BY DEROYAL TO AQUIRE THESE DEVICES WITH NO SUCCESS. THE PACKAGING CONTAINS A 5 YEAR "SHELF LIFE" EXPIRATION DATE. NO ANTICIPATED FAILURE RATE PRIOR TO THE EXPIRING DATE OF THE DEVICE. EXPIRING DATE IS BASED ON PACKAGING. CUSTOMER APPROVED FOR USE THE CONVENIENCE KIT 77-4000305 FOR THEIR CATH LAB. CATH LAB HAS NEVER FILED A COMPLAINT ON MFR'S CONVENIENCE KIT. CUSTOMER AKSED ANOTHER OF IT'S CATH LABS TO SAMPLE THE CONVENIENCE KIT 77-4000305 THAT INITIAL CATH LAB WAS USING. THEY DID SAMPLE THE CONVENIENCE KIT AND LIKED IT; HOWEVER, THEY REQUESTED A FEW CHANGES BE MADE. THE CHANGES WERE MADE AND MANUFACTURING ERRORS OCCURRED ON THE FIRST MANUFACTURING RUN. THEY DID NOT GET WHAT THEY WERE EXPECTING AND COMPLAINTS WERE FILED, BACK ORDER ISSUES AROSE AND REPLACEMENTS WERE SHIPPED, MFR BELIEVES THE ISSUES THAT CATH LAB HAS EXPERIENCED WITH THEIR CONVENIENCE PACKS ARE DUE TO CUSTOMER NOT GETTING WHAT THEY WERE EXPECTING THE FIRST TIME AND NOT REFERRING TO THE CUSTOMER STATEMENTS INCLUDED WITH THE KITS. MFR HAS HAD NO OTHER COMPLAINTS FROM THIS CUSTOMER. THE CUSTOMER CONTINUES TO USE THE KITS.

    Description of Event or Problem · 1

    BEGAN USING DEROYAL PRODUCT 2002-FIRST SHIPMENT OF KITS HAD MULTIPLE PROBLEMS. WASTE BAGS DID NOT HAVE ONE-WAY VALVES, APPROX 3-5 BAGS BROKE OFF AFTER LUERER LOCK. WRONG SIZE NEEDLES IN KIT, 0 DYE SYRINGE. LARGE GAUGE DYE TUBING CREATING TURBULANCE IN LINE ABLE TO CREATE BUBBLES. NEXT SHIPMENT-EXPERIENCED PROBLEMS WITH TRANSDUCER, UNABLE TO HOLD A "0" BALANCE, WAVE FORM DRIFTING (MISPLACED LOT NO. FROM THIS SHIPMENT). NOTE: WORKED WITH SALES REP AND CLINICAL REP WHO DID SUBSTITUTE PRODUCTS FROM PROBLEMS - SOME OF SUBSTITUTION WERE INCORRECT, THE PROBLEM WOULD BE OK FOR ONE SHIPMENT BUT THEN THE INCORRECT PRODUCT WOULD SHOW UP FOR NEXT PRODUCT. TRANSDUCER BECAME MAJOR PROBLEM WITH BALANCING AND MAINTAINING A BALANCE. ASKED BOTH REPRESENTATIVES FOR QA CONTACT FROM DEROYAL, WHICH WAS NOT PROVIDED IMMEDIATELY. EVENTUALLY THE QA DEPT, CONTACTED FACILITY AFTER TWO MONTHS. FACILITY HAS CONTINUED TO HAVE PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 72" VENTED MACRO DR SUBSTITUTE TUBING LRO DEROYAL * *
    2 OTTAWA TRANSDUCER TRANSDUCER LRO DEROYAL * *
    3 LT HEART KIT LT HEART KIT LRO DEROYAL * *
    4 BAG BAG LRO DEROYAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other