COBAS P 471 CENTRIFUGE UNIT
Report
- Report Number
- 1823260-2024-00238
- Event Type
- Injury
- Date Received
- January 26, 2024
- Date of Event
- May 12, 2021
- Report Date
- May 8, 2024
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- JQP
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
IT HAS BEEN DETERMINED THAT THE SYSTEM WAS NOT TURNED OFF AT THE TIME THE EVENT OCCURRED. THE OPERATORS PUT MAGNETS ON THE DOOR TO KEEP THE SYSTEM IN OPERATION WITH THE DOORS OPEN. INVESTIGATIONS DETERMINED THERE WAS NO MALFUNCTION OF THE DEVICE.
H6 INVESTIGATION FINDINGS CODES AND INVESTIGATION CONCLUSION CODES WERE UPDATED.
THE COMPONENT CODE HAS BEEN UPDATED.
THE INVESTIGATION DID NOT IDENTIFY A PRODUCT ISSUE. MEDWATCH FIELD E1 FACILITY NAME - THE FULL FACILITY NAME WAS PROVIDED AS "DRK-BLUTSPENDEDIENST GGMBH BADEN-WÜRTTEMBERG-HESSEN INSTITUTE FRANKFURT/MAIN INST. FÜR TRANSFUSIONSMEDIZN".
IT WAS REPORTED THAT A ROCHE SERVICE TECHNICIAN HIT HIS HEAD ON A COBAS P 471 CENTRIFUGE UNIT WHILE REPAIRING IT. THE TECHNICIAN REPORTEDLY SUSTAINED A LACERATION. THE LACERATION WAS REPORTED TO BE CLOSED WITH STAPLES WHILE THE TECHNICIAN WAS IN AN AMBULANCE. IT WAS REPORTED THAT NO SUBSEQUENT COMPLICATIONS WERE OBSERVED FOR THE TECHNICIAN. FURTHER INFORMATION REGARDING THE CIRCUMSTANCES OF THE INCIDENT WAS REQUESTED BUT NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1395350 | COBAS P 471 CENTRIFUGE UNIT | AUTOMATED CENTRIFUGE UNIT | JQP | ROCHE DIAGNOSTICS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |