DAKO COVERSTAINER
Report
- Report Number
- 3003423869-2024-00014
- Event Type
- Malfunction
- Date Received
- February 26, 2024
- Date of Event
- February 7, 2024
- Report Date
- June 27, 2024
- Manufacturer
- AGILENT TECHNOLOGIES SINGAPORE (INTL.) PTE LTD.
- Product Code
- KPA
- UDI-DI
- 05700571112571
- Removal / Correction Number
- Z-1919-2024
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION THAT RECALL REFERENCE NUMBER, (B)(4), HAS BEEN RECEIVED. AGILENT TECHNOLOGIES RECALL, REFERENCE NUMBER (B)(4), HAS BEEN INITIATED APRIL 2024 WITH THE SCOPE OF NOTIFYING ALL COVER-STAINER CUSTOMERS OF THE FOLLOWING ISSUE: THE LOWER DOOR THAT OPENS TO THE REAGENT BOTTLES IS CRACKING AND/OR BREAKING OFF IN THE UPPER CORNER OF THE PLEXIGLASS. CAPA01211 HAS ADDRESSED THE ISSUE AND THE INVESTIGATION HAS BEEN COMPLETED. AGILENT TECHNOLOGIES HAS DETERMINED THE ROOT CAUSE AS SUCH; THE LOWER DOOR SUPPORT BRACKET, WHICH CONNECTS THE HINGES TO THE LOWER DOOR, IS ONLY ATTACHED TO THE PLEXIGLASS AND NOT TO THE METAL FRAME WHICH IS THE MAIN SUPPORT STRUCTURE OF THE LOWER DOOR. THE WEIGHT OF THE PLEXIGLASS DOOR IS IN TURN CRACKING/BREAKING AT THIS JOINT. CUSTOMERS HAVE BEEN NOTIFIED OF THIS ISSUE VIA A CUSTOMER LETTER. AGILENT TECHNOLOGIES WORKED WITH THE MANUFACTURER TO RE-DESIGN THE SUPPORT BRACKET FOR THE LOWER DOOR HINGES, SO THE WEIGHT OF THE LOWER DOOR ASSEMBLY IS NOT SUPPORTED BY THE PLEXIGLASS, BUT BY THE METAL FRAME OF THE LOWER DOOR. THIS NEW BRACKET IS BEING VERIFIED FOR EFFECTIVENESS; ONCE COMPLETED THIS BRACKET WILL BE INSTALLED AT THE CUSTOMER'S NEXT SERVICE VISIT.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION THAT RECALL NUMBER, Z-1919-2024, HAS BEEN RECEIVED. AGILENT TECHNOLOGIES INITIATED A RECALL APRIL 2024 WITH THE SCOPE OF NOTIFYING ALL COVERSTAINER CUSTOMERS OF THE FOLLOWING ISSUE: THE LOWER DOOR THAT OPENS TO THE REAGENT BOTTLES IS CRACKING AND/OR BREAKING OFF IN THE UPPER CORNER OF THE PLEXIGLASS; RECALL EVENT ID 94439. CAPA01211 HAS ADDRESSED THE ISSUE AND THE INVESTIGATION HAS BEEN COMPLETED. AGILENT TECHNOLOGIES HAS DETERMINED THE ROOT CAUSE AS SUCH; THE LOWER DOOR SUPPORT BRACKET, WHICH CONNECTS THE HINGES TO THE LOWER DOOR, IS ONLY ATTACHED TO THE PLEXIGLASS AND NOT TO THE METAL FRAME WHICH IS THE MAIN SUPPORT STRUCTURE OF THE LOWER DOOR. THE WEIGHT OF THE PLEXIGLASS DOOR IS IN TURN CRACKING/BREAKING AT THIS JOINT. CUSTOMERS HAVE BEEN NOTIFIED OF THIS ISSUE VIA A CUSTOMER LETTER. AGILENT TECHNOLOGIES WORKED WITH THE MANUFACTURER TO RE-DESIGN THE SUPPORT BRACKET FOR THE LOWER DOOR HINGES, SO THE WEIGHT OF THE LOWER DOOR ASSEMBLY IS NOT SUPPORTED BY THE PLEXIGLASS, BUT BY THE METAL FRAME OF THE LOWER DOOR. THIS NEW BRACKET IS BEING VERIFIED FOR EFFECTIVENESS; ONCE COMPLETED THIS BRACKET WILL BE INSTALLED AT THE CUSTOMER'S NEXT SERVICE VISIT.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. AGILENT TECHNOLOGIES HAS INITIATED APRIL 2024 WITH THE SCOPE OF NOTIFYING ALL COVERSTAINER CUSTOMERS OF THE FOLLOWING ISSUE: THE LOWER DOOR THAT OPENS TO THE REAGENT BOTTLES IS CRACKING AND/OR BREAKING OFF IN THE UPPER CORNER OF THE PLEXIGLASS. CAPA01211 HAS ADDRESSED THE ISSUE AND THE INVESTIGATION HAS BEEN COMPLETED. AGILENT TECHNOLOGIES HAS DETERMINED THE ROOT CAUSE AS SUCH; THE LOWER DOOR SUPPORT BRACKET, WHICH CONNECTS THE HINGES TO THE LOWER DOOR, IS ONLY ATTACHED TO THE PLEXIGLASS AND NOT TO THE METAL FRAME WHICH IS THE MAIN SUPPORT STRUCTURE OF THE LOWER DOOR. THE WEIGHT OF THE PLEXIGLASS DOOR IS IN TURN CRACKING/BREAKING AT THIS JOINT. CUSTOMERS HAVE BEEN NOTIFIED OF THIS ISSUE VIA A CUSTOMER LETTER. AGILENT TECHNOLOGIES WORKED WITH THE MANUFACTURER TO RE-DESIGN THE SUPPORT BRACKET FOR THE LOWER DOOR HINGES, SO THE WEIGHT OF THE LOWER DOOR ASSEMBLY IS NOT SUPPORTED BY THE PLEXIGLASS, BUT BY THE METAL FRAME OF THE LOWER DOOR. THIS NEW BRACKET IS BEING VERIFIED FOR EFFECTIVENESS; ONCE COMPLETED THIS BRACKET WILL BE INSTALLED AT THE CUSTOMER'S NEXT SERVICE VISIT.
NO ERRONEOUS STAINING RESULT WAS REPORTED BY THE CUSTOMER IN CONNECTION WITH THIS INCIDENT. NO PATIENT OR USER HARM WAS INDICATED. A1-A6: NOT APPLICABLE. NO PATIENT INVOLVEMENT. WHILE THERE WAS NO DIRECT, OR INDIRECT, USER HARM REPORTED FOR THIS EVENT; IT IS BEING REPORTED DUE TO THE POTENTIAL FOR HARM IF THE EVENT WERE TO REOCCUR. THE INSTRUMENT EXPERIENCED A SIMILAR FAILURE MODE RELATED TO REPORTABLE COMPLAINT WITH INJURY, REFERENCE NUMBER MDR 3003423869-2023-00084, MHRA (B)(4), AGILENT (B)(4). THEREFORE, THIS REPORT IS BEING FILED AS PART OF AGILENT'S COMMITMENT TO DUE DILIGENCE REPORTING.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
THE UNITED KINGDOM CUSTOMER REPORTED THE LOWER FRONT DOOR OF THE COVERSTAINER INSTRUMENT HAS BROKEN IN THE TOP RIGHT HAND CORNER. IMAGE WAS PROVIDED SHOWING THE UPPER CORNER OF THE LOWER DOOR WAS BROKEN CONFIRMING THE CUSTOMER'S ISSUE. THE USER DID NOT SUSTAIN ANY INJURIES. THE CUSTOMER WAS ABLE TO COMPLETE STAINING WITH THE SAME INSTRUMENT. THE FIELD SERVICE ENGINEER (FSE) SERVICED THE INSTRUMENT AND REPLACED THE LOWER DOOR AND SHOCK ABSORBERS. THE INSTRUMENT HAS BEEN REPAIRED, IT IS FULLY OPERATIONAL AND IS AVAILABLE TO THE USER. DIAGNOSTICS WERE NOT ALTERED. THERE WAS NO DIRECT OR INDIRECT PATIENT HARM OR USER HARM REPORTED. THE INVESTIGATION IS ONGOING, CAPTURED IN CAPA01211, AND A SUPPLEMENTAL WILL BE PROVIDED WHEN NEW PERTINENT INFORMATION IS RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1669317 | DAKO COVERSTAINER | AUTOMATED SLIDE STAINER | KPA | AGILENT TECHNOLOGIES SINGAPORE (INTL.) PTE LTD. | CS100 | 05700571112571 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |