MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2009-04-16 for U070 TINA SINGLE PUMP LCD S1000L3 manufactured by Baxter Healthcare - Largo.
[1049109]
The foreign facility reported that approximately one hour after hemodialysis therapy via a tina device was started, the patient experienced low venous pressure and the needle was found loosened from the venous access, and blood loss (amount unknown occurred. The patient required return of the blood via the tina device and 250ml of substitute plasma and, 2 units of red blood cells were administered to the patient. The needle and bloodline lines were not baxter products. The baxter field service engineer was called to come to the site for an evaluation of the tina device.
Patient Sequence No: 1, Text Type: D, B5
[8327671]
The field service engineer arranged to visit on site and evaluate the tina device. Data of visit is unknown at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423500-2009-00174 |
| MDR Report Key | 1364811 |
| Report Source | 01,05 |
| Date Received | 2009-04-16 |
| Date of Report | 2009-02-26 |
| Date of Event | 2009-02-26 |
| Date Mfgr Received | 2009-02-26 |
| Device Manufacturer Date | 2000-12-01 |
| Date Added to Maude | 2009-04-23 |
| 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 | U070 TINA SINGLE PUMP LCD |
| Generic Name | 87FKP |
| Product Code | FKP |
| Date Received | 2009-04-16 |
| Catalog Number | S1000L3 |
| Lot Number | NA |
| 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 | 2009-04-16 |