AVANTI JXN-26
Report
- Report Number
- 3007448124-2025-00001
- Event Type
- Malfunction
- Date Received
- January 28, 2025
- Date of Event
- January 14, 2025
- Report Date
- April 21, 2025
- Manufacturer
- BECKMAN COULTER, INC.
- Product Code
- JQC
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INVESITGATION IS ONGOING. BEC IS ATTEMPTING TO RETRIEVE THE INSTRUMENT FROM THE CUSTOMER SITE. UPDATES WILL BE SUBMITTED AS NEW INFORMATION BECOMES AVAILABLE. FOLLOW UP 1: SECTION B4 WAS UPDATED TO CLARIFY THAT THE INSTRUMENT INVOLVED IN THE EVENT IS A NON-IVD WITH A SIMILAR MEDICAL DEVICE AND TO DOCUMENT THER WAS NO DEATH, OR INJURY AS A RESULT OF THIS EVENT. FOLLOW UP 2: THE CUSTOMER HAS AGREED TO RETURN THE INSTRUMENT TO THE BECKMAN COULTER MANUFACTURING SITE IN ORDER TO CARRY OUT A THOROUGH INSPECTION. THE CUSTOMER AGREES TO SHIP THE INSTRUMENT WITHIN 60 DAYS. THE CUSTOMER WILL RECEIVE A REPLACEMENT. BEC INTERNAL IDENTIFIER - CASE-(B)(4).
FOLLOW UP 03: ONGOING ATTEMPTS HAVE BEEN MADE BY BECKMAN COULTER TO RETRIEVE AND REPLACE THE INSTRUMENT INVOLVED IN THE REPORTED EVENT. WITHOUT INSPECTING THE INSTRUMENT ASSIGNABLE CAUSE CANNOT BE DETERMINED. NO FURTHER UPDATES ARE AVAILABLE WITH THE INFORMATION AVAILABLE. BEC INTERNAL IDENTIFIER - (B)(4).
INVESITGATION IS ONGOING. ADDITIONAL INFORMATION REGARDING THE EVENT HAS BEEN REQUESTED. BEC IS ATTEMPTING TO RETRIEVE THE INSTRUMENT FROM THE CUSTOMER SITE. UPDATES WILL BE SUBMITTED AS NEW INFORMATION BECOMES AVAILABLE. FOLLOW UP 1: SECTION B4 WAS UPDATED TO CLARIFY THAT THE INSTRUMENT INVOLVED IN THE EVENT IS A NON-IVD WITH A SIMILAR MEDICAL DEVICE AND TO DOCUMENT THER WAS NO DEATH, OR INJURY AS A RESULT OF THIS EVENT. BEC INTERNAL IDENTIFIER - CASE-(B)(4).
INVESITGATION IS ONGOING. ADDITIONAL INFORMATION REGARDING THE EVENT HAS BEEN REQUESTED. A FOLLOW UP REPORT WILL BE SUBMITTED AS NEW INFORMATION BECOMES AVAILABLE. BEC INTERNAL IDENTIFIER - CASE-(B)(4).
THE CUSTOMER REPORTED THAT THEIR AVANTI JXN-26 CENTRIFUGE (A NON-IVD INSTRUMENT WITH A SIMILAR MEDICAL DEVICE, ITEM NUMBER B38629) WAS RUNNING AT 7600 RPM (WITH ROTOR JLA-8.1000). A LOUD NOISE WAS HEARD AND THE CENTRIFUGE SHIFTED FROM ITS ORIGINAL POSITION. THE DOOR WAS BROKEN AND OPEN LAUNCHING ONE OF THE CANNISTERS OUT OF THE CENTRIFUGE. THE CUSTOMER WAS CONFIRMED THAT THERE WAS NO DEATH, CAUSTIC OR BIOHAZARD EXPOSURE, OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT. THE INVESTIGATION IS ONGOING.
THE CUSTOMER REPORTED THAT THEIR AVANTI JXN-26 CENTRIFUGE (A NON-IVD INSTRUMENT WITH A SIMILAR MEDICAL DEVICE, ITEM NUMBER B38629) WAS RUNNING AT 7600 RPM (WITH ROTOR JLA-8.1000). A LOUD NOISE WAS HEARD AND THE CENTRIFUGE SHIFTED FROM ITS ORIGINAL POSITION. THE DOOR WAS BROKEN AND OPEN LAUNCHING ONE OF THE CANNISTERS OUT OF THE CENTRIFUGE. THE CUSTOMER WAS CONFIRMED THAT THERE WAS NO DEATH, CAUSTIC OR BIOHAZARD EXPOSURE, OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT. THE INVESTIGATION IS ONGOING.
THE CUSTOMER REPORTED THAT THEIR AVANTI JXN-26 CENTRIFUGE (A NON-IVD INSTRUMENT) WAS RUNNING AT 7600 RPM (WITH ROTOR JLA-8.1000). A LOUD NOISE WAS HEARD AND THE CENTRIFUGE SHIFTED FROM ITS ORIGINAL POSITION. THE DOOR WAS BROKEN AND OPEN LAUNCHING ONE OF THE CANNISTERS OUT OF THE CENTRIFUGE. THE INFORMATION PROVIDED BY THE CUSTOMER DOES NOT STATE THAT THERE WERE ANY INJURIES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2398183 | AVANTI JXN-26 | CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE | JQC | BECKMAN COULTER, INC. | AVANTI JXN-26 200V/208V/240V 50/60 HZ 24A-NON-IVD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |