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 2017-06-20 for STATSPIN SSVT-1 CENTRIFUGE X00-003917-001 manufactured by Iris International.
[78060382]
The beckman coulter customer technical support advised the customer to return the unit. The distributor, (b)(4), supplied a replacement centrifuge unit to the customer to resolve the issue. The centrifuge was received for further investigation and the gasket bowl was found to be cracked. The beckman coulter internal identifier for this event is (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[78060383]
The customer stated the rt12 rotor broke and escaped during centrifugation from their statspin ssvt-1 centrifuge unit. The customer confirmed the safety shield was in use at the time of the event. There is no report of injury to the operator due to this event and no medical attention was needed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2023446-2017-00004 |
| MDR Report Key | 6653896 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-06-20 |
| Date of Report | 2017-06-06 |
| Date of Event | 2017-06-05 |
| Date Mfgr Received | 2017-06-06 |
| Device Manufacturer Date | 2017-07-02 |
| Date Added to Maude | 2017-06-20 |
| 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 | GOPAL MOHANTY |
| Manufacturer Street | 9172 ETON AVENUE |
| Manufacturer City | CHATSWORTH CA 91311 |
| Manufacturer Country | US |
| Manufacturer Postal | 91311 |
| Manufacturer Phone | 8185277379 |
| Manufacturer G1 | IRIS INTERNATIONAL |
| Manufacturer Street | 9172 ETON AVENUE |
| Manufacturer City | CHATSWORTH CA 91311 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91311 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Removal Correction Number | FA-24395 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STATSPIN SSVT-1 CENTRIFUGE |
| Generic Name | CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE |
| Product Code | JQC |
| Date Received | 2017-06-20 |
| Model Number | NA |
| Catalog Number | X00-003917-001 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IRIS INTERNATIONAL |
| Manufacturer Address | 9172 ETON AVENUE CHATSWORTH CA 91311 US 91311 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-20 |