MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-05-06 for STATSPIN MP X00-003917-001 manufactured by Iris International.
[17578964]
Customer reported rotor failure leading to breakage of internal parts during operation causing spillage.
Patient Sequence No: 1, Text Type: D, B5
[17787736]
Statspin centrifuge rotor breakage during operation caused feline blood products/fluids spillage; un-contained outside of centrifuge. The lid of centrifuge broke-off at the hinge. Customer reported that the centrifuge drive was still spinning until it was unplugged. No injuries reported including during clean-up. A ring of blood exists in the bowl of the centrifuge, that there was blood and debris on the bench. The feline sample was from an animal that did not have any disease infections of either animals, or humans, and did not have any disease reportable to the fda or usda. Customer did not know when rotor rt12 was last replaced.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2023446-2014-00050 |
| MDR Report Key | 3902117 |
| Report Source | 05,06 |
| Date Received | 2014-05-06 |
| Date of Report | 2014-04-07 |
| Date of Event | 2014-04-07 |
| Date Mfgr Received | 2014-04-07 |
| Device Manufacturer Date | 2001-07-01 |
| Date Added to Maude | 2014-07-15 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | SUDHA GUPTA |
| Manufacturer Street | 9172 ETON AVE |
| Manufacturer City | CHATSWORTH CA 91311 |
| Manufacturer Country | US |
| Manufacturer Postal | 91311 |
| Manufacturer Phone | 8185277272 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STATSPIN MP |
| Generic Name | STATSPIN CENTRIFUGE |
| Product Code | GKG |
| Date Received | 2014-05-06 |
| Catalog Number | X00-003917-001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IRIS INTERNATIONAL |
| Manufacturer Address | 9172 ETON AVE. CHATSWORTH CA 91311 US 91311 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-05-06 |