inforMED
InjuryCDD

DXA 5000 FIT INPUT/OUTPUT WITH DECAPPER

Received Mar 2, 2022 · Event occurred Feb 2, 2022

Report 3006655511-2022-00002 · MDR key 13654635

Device

Generic name

Radioassay, Vitamin B12

Catalog number

C44570

Product problems

  • Appropriate Device Problem Term/Code Not Available
  • Appropriate Device Problem Term/Code Not Available

Patient

Unknown

  • Eye Injury
  • Eye Injury

Narrative

Description of Event or Problem

THE CUSTOMER REPORTED THAT WHEN REMOVING FULL ARCHIVE RACK WITH SAMPLES FROM OUTLET (BACK POSITION) OF THE DXA INSTRUMENT SOME OF PRIMARY TUBES WAS/WERE BLOCKED. THE FRAME NEEDED ADDITIONAL MANIPULATION THAT SERUM WAS SPRAYED OUTSIDE AND ACCIDENTALLY ALSO INTO THE EYES OF TECHNICIAN WORKING WITH INSTRUMENT. THE TECHNICIAN WASHED THEIR EYES AND RECEIVED ANTIBIOTICS. NO FURTHER HARM WAS REPORTED. NO PATIENTS WERE INVOLVED IN THIS INCIDENT.

Additional Manufacturer Narrative

BECKMAN COULTER CUSTOMER TECHNICAL SUPPORT (CTS) PROVIDED SUPPORT AND DOCUMENTED THE DETAILS OF THE EVENT. THE BECKMAN COULTER FIELD SERVICE ENGINEER EVALUATED THE DXA, AND CONFIRMED THAT THE TECHNICIAN STRUGGLED TO REMOVE THE RACK OF TUBES FROM FOR BACK POSITION OF THE DRAWER. THE FSE CONFIRMED THAT THE DRAWERS, ONCE FULLY OPENED, ARE DESIGNED IN SUCH A WAY THAT THE REMOVAL OF A RACK PLACED IN BACK POSITION IS POSSIBLE WITHOUT CONSTRAIN AND IN A SAFE MANNER. POSSIBLE RESISTANCE HAS BEEN DISCUSSED WITH A DXA MECHANICAL ENGINEER, AND IT ORIGINATES IN THE INNER SLIDERS FROM THE DRAWERS, WHICH GET "STACKED" WITH TIME, AND NEED TO BE "FIRMLY PULLED" PERIODICALLY TO ENSURE FULL RANGE OF MOTION OF THE OPENED RACK. THE ISSUE WILL CONTINUE TO BE EVALUATED. INITIAL REPORTER TELEPHONE NUMBER IS (B)(6). THE BECKMAN COULTER INTERNAL IDENTIFIER IS (B)(4).

Description of Event or Problem

THE CUSTOMER REPORTED THAT WHEN REMOVING FULL ARCHIVE RACK WITH SAMPLES FROM OUTLET (BACK POSITION) OF THE DXA INSTRUMENT SOME OF PRIMARY TUBES WAS/WERE BLOCKED. THE FRAME NEEDED ADDITIONAL MANIPULATION THAT SERUM WAS SPRAYED OUTSIDE AND ACCIDENTALLY ALSO INTO THE EYES OF TECHNICIAN WORKING WITH INSTRUMENT. ON (B)(6) 2022, THE TECHNICIAN CONFIRMED THAT THEY WASHED THEIR EYES AND RECEIVED TREATMENT WITH ANTIBIOTICS. NO FURTHER HARM WAS REPORTED. NO PATIENTS WERE INVOLVED IN THIS INCIDENT.