MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-11 for STATSPIN SSVT CENTRIFUGE SSVT-1 CENTRIFUGE X00-003917-001 manufactured by Beckman Coulter.
[111164128]
Beckman coulter initiated an rma (return material authorization) for replacement of the customer? S centrifuge. The distributor, (b)(4), supplied a new replacement unit to the customer to resolve the issue. Beckman coulter internal identifier is (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[111164129]
The customer reported the rt12 rotor broke during centrifugation of the statspin ssvt-1 centrifuge. The customer stated that the safety shield was in use at the time of the event. The customer stated that pieces of the rotor had escaped from the ssvt- 1 centrifuge, traveled a few feet and hit a cabinet. There are no reports of harm or injury; thus, no medical attention was received due to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2050012-2018-01001 |
| MDR Report Key | 7589309 |
| Date Received | 2018-06-11 |
| Date of Report | 2018-06-05 |
| Date of Event | 2018-05-15 |
| Date Mfgr Received | 2018-05-15 |
| Device Manufacturer Date | 2011-11-28 |
| Date Added to Maude | 2018-06-11 |
| 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 | MR. DAVID DAVIS |
| Manufacturer Street | 250 S. KRAEMER BLVD. M/S E1.SE.01 |
| Manufacturer City | BREA CA 928218000 |
| Manufacturer Country | US |
| Manufacturer Postal | 928218000 |
| Manufacturer Phone | 7149613796 |
| Manufacturer G1 | BECKMAN COULTER |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 928218000 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 928218000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STATSPIN SSVT CENTRIFUGE |
| Generic Name | CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE |
| Product Code | JQC |
| Date Received | 2018-06-11 |
| Model Number | SSVT-1 CENTRIFUGE |
| Catalog Number | X00-003917-001 |
| 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 S. KRAEMER BLVD. BREA CA 928218000 US 928218000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-11 |