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 2018-05-01 for AVANTI J-25 CENTRIFUGE 363102 manufactured by Beckman Coulter.
[107592558]
Per the field service engineer (fse), upon initial evaluation of the centrifuge he confirmed that the interlock did not trigger the circuit breaker when the front panel was removed. The fse replaced the failed circuit breaker to resolve the issue. The beckman coulter internal identifier for this event is (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[107592559]
The customer reported that the avanti j-25 centrifuge generated a d1 error and there was a spark seen near the power distribution board of the j-25 unit while the front panel was removed. Upon investigation it was determined that the customer was in close proximity to components with line voltage while accessing the door release. The interlock did not trigger the circuit breaker when the front panel was removed. Additionally, the customer failed to unplug the instrument while performing emergency access (as instructed in the ifu), resulting in the exposure risk. There was no death or serious injury related to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007448124-2018-00002 |
| MDR Report Key | 7477530 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-05-01 |
| Date of Report | 2018-04-03 |
| Date of Event | 2018-04-03 |
| Date Mfgr Received | 2018-04-03 |
| Device Manufacturer Date | 2002-12-01 |
| Date Added to Maude | 2018-05-01 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. LAURIE O'RIORDAN |
| Manufacturer Street | 11800 SW 147TH AVE 32-L23 |
| Manufacturer City | MIAMI FL 33196 |
| Manufacturer Country | US |
| Manufacturer Postal | 33196 |
| Manufacturer Phone | 3053802874 |
| Manufacturer G1 | BECKMAN COULTER |
| Manufacturer Street | 11800 SW 147TH AVE |
| Manufacturer City | MIAMI FL 33196 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33196 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AVANTI J-25 CENTRIFUGE |
| Generic Name | CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE |
| Product Code | JQC |
| Date Received | 2018-05-01 |
| Model Number | NA |
| Catalog Number | 363102 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Manufacturer Address | 250 SOUTH KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-01 |