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 2018-11-28 for STATSPIN SSVT-1 CENTRIFUGE X00-003917-001 manufactured by Beckman Coulter.
[128924967]
The customer acknowledge they failed to follow instructions to use the plastic inner shield during spin cycles as required. Customer technical support (cts) provided customer with most recent statspin safety notice, safety shield and a trained customer with importance of installing shield. The customer confirmed there was no damage to lid, hinge or latch of centrifuge. Cts initiated return merchandise authorization (rma) process to return centrifuge for repair. The customer was provided with a replacement centrifuge to resolve the issue. Beckman coulter internal identifier is case- (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[128924968]
The customer reported statspin ssvt-1 centrifuge rotor broke during use and broken rotor pieces hit a lab associate in the leg. There was no adverse event reported. The associate did not seek medical attention for the incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2050012-2018-01039 |
| MDR Report Key | 8113289 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-11-28 |
| Date of Report | 2018-11-28 |
| Date of Event | 2018-10-22 |
| Date Facility Aware | 2018-11-16 |
| Date Mfgr Received | 2018-11-16 |
| Device Manufacturer Date | 2012-10-22 |
| Date Added to Maude | 2018-11-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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. |
| 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 |
| 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 | 2018-11-28 |
| 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 | 1. Other | 2018-11-28 |