BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC.T 5DIFF CAP PIERCE (CP)

    MDR report key: 2251231 · Received September 9, 2011

    Report

    Report Number
    1061932-2011-01380
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 4, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K042173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PER LABELING, BECKMAN COULTER, INC., URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IT IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LAB ANALYZER. THE CUSTOMER REPORTED THE INCIDENT STARTED AFTER THE FIELD SERVICE ENGINEER (FSE) REPLACED AND ALIGNED THE INSTRUMENT'S PROBE; IN ADDITION TO CHANGING THE TUBE HOLDER. HOWEVER, WHEN FSE RETURNED TO SERVICE THE UNIT THE INSTRUMENT'S PERFORMANCE WAS VERIFIED AND CONFIRMED THE ANALYZER HAD MET SPECIFICATIONS. THE ROOT CAUSE COULD NOT BE DETERMINED BASED ON AVAILABLE INFO. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN JANUARY 1, 2008 THROUGH OCTOBER 23, 2010 OF COMPLAINTS FOR ADD¿L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE ACT 5DIFF CONTROL PLUS (LOW CONTROL) WAS LEAKING AT THE CENTER OF THE CAP AFTER PIERCES FROM THE ACT 5DIFF INSTRUMENT PROBE. THE PIERCING WAS MADE RIGHT ON THE CENTER LEAVING A LARGE HOLE IN THE CORE OF THE CAP. CONTROLS COULD EASILY LEAK OUT HAVING THE POTENTIAL OF BIOHAZARD EXPOSURE AND CAUSING TO USE THE CONTROL MORE RAPIDLY THAN NORMALLY. THE USER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF LAB COAT AND GLOVES AT THE TIME OF THE INCIDENT. NO INJURIES OCCURRED AND MEDICAL ATTENTION WAS NOT SOUGHT AS A RESULT OF THIS EVENT. THERE WAS NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT REVIEWED; HOWEVER, IT IS READILY AVAILABLE. THE LAB'S EXPOSURE CONTROL OR RISK MGMT PLANS ARE IN PLACE. THERE WAS NO DEATH, INJURY OR CHANGE TO PT TREATMENT ATTRIBUTED OR ASSOCIATED TO THIS COMPLAINT. REPLACEMENT CONTROLS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER AC.T 5DIFF CAP PIERCE (CP) GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ACT 5 DIFF CONTROL PLUS| (B)(4) (OPT)| TUBE HOLDERS (B)(4) (STD)