MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2009-05-14 for 29400-K manufactured by Ascent Healthcare Solutions.
[1266186]
The customer was using a tissue stabilizer in an open heart off pump procedure without the canister and reported that blood backed up in the tubing and the machine shut down. The procedure time was extended by 30 mins. There was no pt injury or adverse outcome reported.
Patient Sequence No: 1, Text Type: D, B5
[8432753]
The device was returned to ascent healthcare solutions without any labeling or sales order info. Therefore, the lot number, manufacture date and expiration date could not be determined. The customer stated that a canister was not used with the stabilizer because they did not have one that fit the device. Ascent healthcare solution's ifu states: "connect other end of the non-filter tubing set to a fluid collection container (not supplied). "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2090040-2009-00002 |
| MDR Report Key | 1416706 |
| Report Source | 05,06,07 |
| Date Received | 2009-05-14 |
| Date of Report | 2009-05-01 |
| Date of Event | 2009-04-01 |
| Date Mfgr Received | 2009-04-02 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MOIRA BARTON-VARTY |
| Manufacturer Street | 10232 S. 51ST STREET |
| Manufacturer City | PHOENIX AZ 85044 |
| Manufacturer Country | US |
| Manufacturer Postal | 85044 |
| Manufacturer Phone | 4807635300 |
| Manufacturer G1 | ASCENT HEALTHCARE SOLUTIONS |
| Manufacturer Street | 10232 S. 51ST STREET |
| Manufacturer City | PHOENIX AZ 85044 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 85044 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NA |
| Product Code | NQG |
| Date Received | 2009-05-14 |
| Returned To Mfg | 2009-04-09 |
| Model Number | 29400-K |
| Catalog Number | 29400-K |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASCENT HEALTHCARE SOLUTIONS |
| Manufacturer Address | PHOENIX AZ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-05-14 |