MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2008-12-08 for AXP AUTOXPRESS PLATFORM 8-5101 manufactured by Thermogenesis Corp..
[1020438]
A customer call came in on (b)(6)2008, to report that white debris was found in the disposable freezing bag.
Patient Sequence No: 1, Text Type: D, B5
[8130898]
We have completed our eval of the returned disposable bagset. The white debris was sent out for fourier transform infrared (ftir) spectroscopy for identification. The particle was identified as bagset stopcock material. This is an isolated event for this lot of disposable bagsets from this mfr. We will continue to monitor and trend. No adverse events have been reported for this occurrence.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2950374-2008-00003 |
| MDR Report Key | 1258146 |
| Report Source | 04 |
| Date Received | 2008-12-08 |
| Date of Report | 2008-12-08 |
| Date of Event | 2008-11-11 |
| Date Mfgr Received | 2008-11-11 |
| Device Manufacturer Date | 2008-02-01 |
| Date Added to Maude | 2009-12-28 |
| 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, MGR |
| Manufacturer Street | 2711 CITRUS RD. |
| Manufacturer City | RANCHO CORDOVA CA 95742 |
| Manufacturer Country | US |
| Manufacturer Postal | 95742 |
| Manufacturer Phone | 9168585109 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AXP AUTOXPRESS PLATFORM |
| Product Code | OAO |
| Date Received | 2008-12-08 |
| Returned To Mfg | 2008-11-13 |
| Model Number | 8-5101 |
| Catalog Number | 8-5101 |
| Lot Number | 27066-0000-02 |
| ID Number | NA |
| Device Expiration Date | 2009-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2008-12-08 |