BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBE CENTRYSTEM 3

    MDR report key: 56495 · Received December 17, 1996

    Report

    Report Number
    1713683-1996-00282
    Event Type
    Malfunction
    Date Received
    December 17, 1996
    Report Date
    December 16, 1996
    Manufacturer
    GAMBRO HEALTHCARE
    Product Code
    FII
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LIP THAT HOLDS THE CAM IS EITHER WORN AND/OR BROKE OFF AND THE CAMS ARE FALLING OUT OR NOT OCCLUDING THE TUBING SET. THEREE WERE NO PT INJURIES OR MEDICAL INTERVENTIONS REPORTED. THERE WERE NO RELATED CPF DEFECTS REPORTED FOR THIS MACHINE. TEST PROCEDURE FOLLOWED: QARA 146 SECTION 9.0, REVISION G. MFG SPECIFICATIONS TESTED TO (IF NOT CLEARLY ESTABLISHED IN TEST PROCEDURE): VISUAL. THE RETURNED FOUR-POSITION LINE CLAMP WAS VISUALLY INSPECTED AND CONFIRMED THAT CLAMP HOLDER WAS BROKEN. TABS ON WHITE CLAMP INSERT HOLDER WAS BROKEN OR STRETCHED, ALLOWING INSERTS TO FALL OUT OF THE HOLDER. IT WAS ALSO DETERMINED THAT THE RETURNED CLAMP STOP TABS WHICH HOLD CLAMP IN OCCLUDED POSITION WERE EITHER WORN OR BROKEN, SO THAT CLAMP NO LONGER STOPPED SECURELY IN CLOSED POSITION. THIS CONDITION OCCURRED WITH NORMAL USE. THE ABOVE INFO INDICATES THAT THE LINE CLAMP FAILURE DESCRIBED IN THIS COMPLAINT WAS GENERATED BY A BROKEN CLAMP ASSEMBLY. THIS ISSUE WILL CONTINUE TO BE TRENDED AS PART OF THE GAMBRO HEALTHCARE CORRECTIVE ACTION SYSTEM AND MANAGEMENT REVIEW TEAM. ANY FURTHER INVESTIGATIONS, ANALYSES, AND/OR CORRECTIVE ACTIONS TAKEN ON THIS COMPLAINT ISSUE WILL BE DETERMINED BY AND DOCUMENTED IN THIS CORRECTIVE ACTION REVIEW PROCESS. SEE FAR# 960027. FAILURE CODES: F. CODE SLNCL 902ET. CUSTOMER CONTACTED: NO. SALES/SERVICE CONTACTED BY INVESTIGATOR? NO. TRAINING REQUIRED? NO.

    Description of Event or Problem · 1

    DURING A DIALYSIS TREATMENT, THE 4 POSITION LINE CLAMP WAS MISSING THE HEPARIN LINE CLAMP PIN. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBE CENTRYSTEM 3 DIALYSIS CONTROL UNIT FII GAMBRO HEALTHCARE NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other