MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2009-03-17 for TINA SYSTEM 1000 MACHINE USED - EXCELLENT CONDITION SYS1000-L3PE A09 manufactured by Baxter Healthcare - Largo.
[1070761]
The facility nurse reported a pt experienced cough and tightness in the chest during hemodialysis therapy on the tina 1000 machine. Possible air embolism was considered. Oxygen (liter flow rate unknown) was applied and after 15 mins, the pt's symptoms resolved. The pt finished the hemodialysis therapy successfully. No other information is currently available.
Patient Sequence No: 1, Text Type: D, B5
[8223152]
An on site visit was conducted in 2009. The evaluation results are pending.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423500-2009-00142 |
| MDR Report Key | 1346472 |
| Report Source | 01,05 |
| Date Received | 2009-03-17 |
| Date of Report | 2009-02-25 |
| Date of Event | 2009-02-23 |
| Date Mfgr Received | 2009-02-25 |
| Date Added to Maude | 2009-03-25 |
| 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 | KAREN KIRBY |
| Manufacturer Street | 25212 W. ILLINOIS ROUTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 8472704541 |
| Manufacturer G1 | BAXTER HEALTHCARE - LARGO |
| Manufacturer Street | 7511 114TH AVE. NORTH |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33773 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TINA SYSTEM 1000 MACHINE USED - EXCELLENT CONDITION |
| Generic Name | 78FKP |
| Product Code | FKP |
| Date Received | 2009-03-17 |
| Catalog Number | SYS1000-L3PE A09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE - LARGO |
| Manufacturer Address | LARGO FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-03-17 |