MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2009-04-22 for AXP PROCESSING SET 8-5101 manufactured by Thermogenesis Corp..
[1144771]
The initial report received (b)(6) 2009 indicated that a hole was observed in the plasma bag close to the valve after centrifugation. This could possibly result in a sample loss.
Patient Sequence No: 1, Text Type: D, B5
[8141681]
The axp processing bag is the component of the axp platform unit and are single use. The info received from the user indicated there was a hole in the plasma bag close to the valve after centrifugation. Product has been received and is under investigation. This type of occurrence poses no risk to pt or caregiver. No adverse event has been reported for this occurrence. To ensure compliance to the fda reporting requirements under section 21cf803. Thermogenesis has taken a conservative approach and made the decision to submit these types of occurrences..
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2950374-2009-00001 |
| MDR Report Key | 1369388 |
| Report Source | 00 |
| Date Received | 2009-04-22 |
| Date of Report | 2009-04-21 |
| Date of Event | 2009-03-30 |
| Date Mfgr Received | 2009-03-30 |
| Device Manufacturer Date | 2008-06-01 |
| Date Added to Maude | 2011-03-21 |
| 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 | JEFF BROWNING |
| Manufacturer Street | 2711 CITRUS RD |
| Manufacturer City | RANCHO CORDOVA CA 95742 |
| Manufacturer Country | US |
| Manufacturer Postal | 95742 |
| Manufacturer Phone | 9168585111 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AXP PROCESSING SET |
| Product Code | OAO |
| Date Received | 2009-04-22 |
| Returned To Mfg | 2009-03-31 |
| Model Number | 8-5101 |
| Catalog Number | 8-5101 |
| Lot Number | 28204-0000-01 |
| ID Number | NA |
| Device Expiration Date | 2009-06-26 |
| Operator | OTHER |
| 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 | 2009-04-22 |