MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-02-13 for J6-MI CENTRIFUGE N/A B25197 manufactured by Beckman Coulter.
[100249480]
The customer was using non-beckman plate carriers at the time of the reported event, and there was damage to the plate carriers, which was determined to be the likely cause of the rotor mishap event. The use of non-beckman plate carriers is considered user error since the instrument instructions for use (ifu) specifies that only beckman coulter rotors and accessories are to be used in the centrifuge. The other instrument issues of the drive belt being out of position and damage to internal centrifuge components were determined to have likely resulted from the rotor mishap and/or the instrument reportedly falling over. The field service engineer (fse) determined the likely cause of the initial rotor mishap to be damaged non-beckman plate carriers, and a possible cause for the reported burning smell to be the drive belt being out of position. In an abundance of caution beckman coulter has reported the event. Internal bec identifier (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[100249481]
The customer reported that there was a rotor mishap and the j6-mi centrifuge instrument fell on its side. There was also a report of a burning smell. There was no injury, smoke, or fire reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007448124-2018-00001 |
| MDR Report Key | 7267913 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-02-13 |
| Date of Report | 2018-01-16 |
| Date of Event | 2018-12-21 |
| Date Mfgr Received | 2018-01-16 |
| Device Manufacturer Date | 2008-06-01 |
| Date Added to Maude | 2018-02-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. LAURIE O'RIORDAN |
| Manufacturer Street | 11800 SW 147TH AVENUE, |
| Manufacturer City | MIAMI FL 331962031 |
| Manufacturer Country | US |
| Manufacturer Postal | 331962031 |
| Manufacturer Phone | 3053802874 |
| Manufacturer G1 | BECKMAN COULTER |
| Manufacturer Street | 5350 LAKEVIEW PARKWAY SOUTH DR |
| Manufacturer City | INDIANAPOLIS IN 46268 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46268 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | J6-MI CENTRIFUGE |
| Generic Name | CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE |
| Product Code | JQC |
| Date Received | 2018-02-13 |
| Model Number | N/A |
| Catalog Number | B25197 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Manufacturer Address | 250 S KRAEMER BLVD BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-13 |