MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2008-10-24 for AXP AUTOXPRESS PLATFORM 8-5101 manufactured by Thermogenesis Corp..
[959172]
The initial report relating to this event was received on (b) (6) 2008, and describes a situation where a customer was processing a cord blood sample and noticed a white floating particulate in the bagset. Ten add'l instances have been reported through october 23, 2008, where particulates were identified in the rbc bag, processing bag, or freezing bag prior to processing the samples. There have been no add'l reports since that time.
Patient Sequence No: 1, Text Type: D, B5
[8232073]
Add'l lot number: 08c04. The observed white particulate has not been characterized at this reporting time. We have begun investigation. Further info will be provided in a supplement to this report. No adverse event has been reported for this occurrence.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2950374-2008-00001 |
| MDR Report Key | 1212778 |
| Report Source | 00 |
| Date Received | 2008-10-24 |
| Date of Report | 2008-10-23 |
| Date of Event | 2008-10-10 |
| Date Mfgr Received | 2008-10-10 |
| Device Manufacturer Date | 2008-02-01 |
| Date Added to Maude | 2010-04-07 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | TRISTA MADSEN |
| Manufacturer Street | 2711 CITRUS RD. |
| Manufacturer City | RANCHO CORDOVA CA 95742 |
| Manufacturer Country | US |
| Manufacturer Postal | 95742 |
| Manufacturer Phone | 9168585109 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AXP AUTOXPRESS PLATFORM |
| Product Code | OAO |
| Date Received | 2008-10-24 |
| Returned To Mfg | 2008-10-15 |
| Model Number | 8-5101 |
| Catalog Number | 8-5101 |
| Lot Number | 08B13 |
| ID Number | NA |
| Device Expiration Date | 2009-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THERMOGENESIS CORP. |
| Manufacturer Address | 2711 CITRUS RD. RANCHO CORDOVA CA 95742 US 95742 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-10-24 |