BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBE SPECTRA BLOOD COLLECTION

    MDR report key: 3864085 · Received June 10, 2014

    Report

    Report Number
    1722028-2014-00221
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 14, 2014
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    K831004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS RECORD WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF MDR'S, PER FDA REQUEST, TO IDENTIFY RECORDS IN WHICH A SERIOUS INJURY OR MEDICAL INTERVENTION OCCURRED, BUT THE TYPE OF REPORTABLE EVENT WAS NOT INDICATED AS A SERIOUS INJURY IN THE MDR FORM. THIS SUPPLEMENT IS BEING FILED TO MODIFY INFORMATION PER FDA REQUEST.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: PER THE CUSTOMER, THE REPORTED PROCEDURES HAVE BEEN DONE ON ALL OF THEIR MACHINES, AND THIS IS OVER THE COURSE OF A YEAR, WITH MULTIPLE PROCEDURES FOR EACH PATIENT. SOME HAVE OCCURRED 2-3 HOURS AFTER, SOME 30-40 MINUTES AFTER THE PROCEDURES. THE CUSTOMER HAS ATTRIBUTED THE HYPOTENSION TO PATIENT CONDITION AND FLUID SHIFTS, AND HAS NOT CONSIDERED THEM A MECHANICAL OR MACHINE ISSUE. THEY HAVE COMPLETED THEIR OWN INVESTIGATIONS AND HAVE MADE SOME PROCEDURAL CHANGES, INCLUDING FLUIDS AT THE END OF THE PROCEDURE, CALCIUM SUPPLEMENTS, SLOWING THE INLET AND INCREASING THE TIME OF THE PROCEDURE. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE CUSTOMER SITE CONDUCTED THEIR OWN INVESTIGATION AND MADE SOME PROCEDURAL CHANGES THAT WERE FOUND EFFECTIVE IN 2 OUT OF THE 3 PATIENTS. THE THIRD PATIENT STILL REQUIRES PRIME DIVERT AT THE BEGINNING OF THE PROCEDURE AND REQUIRES MORE OBSERVATION BEFORE BEING DISCHARGED PREVENTIVE MAINTENANCE REVIEW AND SERVICE CALLS COULD NOT BE CONDUCTED BECAUSE THE SERIAL NUMBERS INVOLVED AND SPECIFIC INCIDENT DATES WERE NOT PROVIDED BY THE CUSTOMER. THE CUSTOMER DID NOT PROVIDE THE LOT NUMBER PERTAINING TO THIS EVENT, THEREFORE A DEVICE HISTORY RECORD (DHR) SEARCH COULD NOT BE CONDUCTED FOR THIS SPECIFIC INCIDENT. ALL LOTS MUST MEET ACCEPTANCE CRITERIA BEFORE RELEASE. ROOT CAUSE: THIS DISPOSABLE SET WAS UNAVAILABLE FOR SPECIFIC ROOT CAUSE ANALYSIS. THE CUSTOMER REPORTED THAT THEY HAVE ATTRIBUTED THE HYPOTENSION TO PATIENT CONDITION AND FLUID SHIFTS AND HAVE NOT CONSIDERED THEM RELATED TO A MECHANICAL OR MACHINE ISSUE. THE COBE SPECTRA APHERESIS SYSTEM ESSENTIALS GUIDE CAUTIONS TO BE AWARE OF POSSIBLE DONOR OR PATIENT REACTIONS, AND TO BE PREPARED TO TAKE ACTION SHOULD REACTIONS OCCUR.

    Description of Event or Problem · 1

    DURING A TRAINING SESSION, THE CUSTOMER MENTIONED THAT OVER THE LAST FEW YEARS, THEY HAVE SEEN MULTIPLE PATIENT REACTIONS AFTER THE COMPLETION OF RED BLOOD CELL EXCHANGE (RBCX) PROCEDURES. PER THE CUSTOMER, 4-5 PATIENTS CONSISTENTLY HAVE SOME TYPE OF HYPOTENSIVE EPISODE AFTER THE PROCEDURE IS COMPLETED AND THEY ARE DISCONNECTED FROM THE MACHINE. SPECIFIC DATES OF THE EVENTS AND SPECIFIC PATIENT INFORMATION IS NOT AVAILABLE AT THIS TIME. IT IS NOT KNOWN AT THIS TIME IF MEDICAL INTERVENTION WAS NECESSARY FOR ANY OF THE EVENTS. THE DISPOSABLE KITS ARE NOT AVAILABLE FOR RETURN BECAUSE THEY WERE DISCARDED BY THE CUSTOMER. THIS REPORT IS BEING FILED DUE TO INSUFFICIENT INFORMATION PROVIDED AT THIS TIME TO DETERMINE IF A MALFUNCTION WITH THE POTENTIAL FOR INJURY HAS OCCURRED.

    Description of Event or Problem · 1

    FOLLOW-UP COMMUNICATION WITH THE CUSTOMER SHOW THAT THERE WAS NO SHORT TERM MEDICAL INTERVENTION. ON A LONGER-TERM BASIS IT WAS SHOWN THAT 3 PATIENTS REQUIRED SALINE BOLUS OF 200-250 MLS SALINE. ADDITIONALLY, ONE ADULT MALE PATIENT HAS HAD SEVERAL OCCURRENCES WHERE HE HAD TO BE HOSPITALIZED. THE CUSTOMER WAS NOT ABLE TO PROVIDE HOSPITALIZATION DATES AND DETAILS. THE PATIENT INFORMATION IN SECTION A IS FOR THE PATIENT THAT WAS HOSPITALIZED. ADDITIONAL PATIENT INFORMATION WAS NOT PROVIDED BY THE CUSTOMER AFTER MULTIPLE ATTEMPTS TO OBTAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337681 COBE SPECTRA BLOOD COLLECTION COBE SPECTRA RBCX SET GKT TERUMO BCT

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Hospitalization| R