BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTERIAL FOR COBE C2 6.35MM NO CHAMBER

    MDR report key: 164573 · Received April 23, 1998

    Report

    Report Number
    8030665-1998-00758
    Event Type
    Injury
    Date Received
    April 23, 1998
    Date of Event
    April 1, 1998
    Report Date
    April 3, 1998
    Manufacturer
    ERIKA DE REYNOSA
    Product Code
    FJK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PIR#9800764-WAITING FOR SAMPLE ANALYSIS, WILL PROVIDE FOLLOW-UP REPORT. THE ACTUAL SAMPLE WAS REC'D FOR EVALUATION. THE SAMPLE WAS VISUALLY INSPECTED ACCORDING TO PROCEDURE. A SPLIT WAS DETECTED ON THE PUMP SEGMENT. CLOSER INSPECTION DONE POST DECONTAMINATION REVEALED THAT THE SPLIT ON THE PUMP SEGMENT WAS ONE INCH LONG AND ABOUT ONE INCH FROM THE SALINE TEE CONNECTOR. THE SPLIT PENETRATED INTO THE PUMP SEGMENT INNER WALL. NO AIR LEAK TEST WAS PERFORMED AS THE SPLIT PENETRATED THE INNER WALL AND WOULD HAVE CAUSED A LEAK. BASED ON THE SAMPLE ANALYSIS, THE COMPLAINT AS STATED, WAS CONFIRMED. HOWEVER, WE DO NOT BELIEVE THAT THE PROBLEM IS MFG RELATED. THERE IS NO KNOWN SOURCE, WITHIN THE MFG OR ASSEMBLY PROCESS, THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE SPLIT. TUBING CANNOT BE EXTRUDED WITH A SPLIT. THEREFORE WE CAN ONLY SPECULATE THAT THE SPLIT WAS DUE TO USE AND/OR HANDLING. THE SPLIT WAS ROUGH AND APPEARED TO BE RUBBED AND TORN. WE WILL CONTINUE TO MONITOR THIS INFORMATION IN FUTURE TRENDING. A F/U LETTER HAS BEEN SENT TO THE CUSTOMER. COMPLAINT IS CLOSED.

    Description of Event or Problem · 1

    RECEIVED NOTICE COMPLAINT CONCERNING ABOVE PRODUCT FROM CHIEF TECHNICIAN. SPOKE WITH DIRECTOR OF NURSING REGARDING THE EVENT. REPORTS THAT APPROXIMATELY ONE HOUR INTO THE TREATMENT, THE HEALTH CARE PROFESSIONAL CARING FOR THE PT, NOTED BLOOD DRIPPING FROM THE PUMP SEGMENT. REPORTS THAT NO ALARM SOUNDED. TREATMENT WAS STOPPED, LINE CHANGED AND TREATMENT COMPLETED WITHOUT FURTHER INCIDENT. THE ESTIMATED BLOOD LOSS FOR THIS PT WAS APPROXIMATELY 300CC FROM THE LEAK AND LOSS OF EXTRACORPOREAL SYSTEM DUE TO AIR. THE PT REMAINED STABLE DURING THE EVENT. DIRECTOR OF NURSING REPORTS THAT THERE IS A SMALL PINHOLE IN THE PUMP SEGMENT. THE ACTUAL SAMPLE IS AVAILABLE. MEDWATCH FILED FOR BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTERIAL FOR COBE C2 6.35MM NO CHAMBER BLOOD LINE FOR HEMODIALYSIS FJK ERIKA DE REYNOSA NA R7P084

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other DIALYSIS 3X/WEEK.| COBE C2 DIALYSIS MACHINE