BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSION PACK, ADULT CPB, MEDICAL UNIV OF SC, CHARLESTON, S

    MDR report key: 343463 · Received July 19, 2001

    Report

    Report Number
    1718850-2001-00026
    Event Type
    Malfunction
    Date Received
    July 19, 2001
    Date of Event
    June 14, 2001
    Report Date
    July 19, 2001
    Manufacturer
    COBE CARDIOVASCULAR, INC.
    Product Code
    DWF
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    AD'L INFO PROVIDED DURING LATER CONTACT WITH THE CUSTOMER INDICATED THAT THE TUBING THAT SPLIT WAS 1/4" TUBING USED IN A SUCKER APPLICATION; THE TOP AND BOTTOM SPLIT APPROX 4" IN LENGTH. BLOOD LOSS WAS ONLY APPROX 5CC. THE CLINICIANS CUT OUT THE SPLIT SECTION OF TUBING AND CONTINUED TO USE THE REMAINING SECTION. THERE WAS NO PT INJURY REPORTED. THE PT WAS DISCHARGED IN GOOD CONDITION. AS OF JULY 18TH THERE WAS NO PT CONDITION CHANGE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32761 PERFUSION PACK, ADULT CPB, MEDICAL UNIV OF SC, CHARLESTON, S CUSTOM PERFUSION PACK DWF COBE CARDIOVASCULAR, INC. NA *

    Patients

    Seq Age Sex Outcome Treatment
    1