MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2009-10-23 for TINA SYSTEM 1000 MACHINEUSED - EXCELLENT CONDITION SYS1000-L3PE//A09 manufactured by Baxter Healthcare - Largo.
[18513583]
On september 30th, 2009, a nurse reported that an incident of reverse ultrafiltration occurred with a tina system 1000 hemodialysis machine. The nurse reported that after completing the scheduled 4 hour treatment, the patient had noticeable facial edema, increased abdominal girth, generalized edema and dyspnea. After the hemodialysis treatment. This case was considered a reverse ultrafiltration and a new hemodialysis session was initiated for an additional period of 3 hours with an ultrafiltration of 3. 3kg. It was indicated that once the additional hemodialysis treatment was completed, the patient recovered from the symptoms and the patient has been able to continue with hemodialysis after this incident without further complications.
Patient Sequence No: 1, Text Type: D, B5
[18740717]
Evaluation summary: the hemodialysis machine involved in the incident was evaluated by technical services at the customer site and no failures related to the reported issue were found. The machine passed all tests without problems. A service history review was also completed indicating that the machine has been through routine preventive maintenance according to the 2009 schedule. The last failures of the instrument were related to the electronic system (a/d reference alarm) but no failures occurred related to ultrafiltration.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423500-2009-00485 |
| MDR Report Key | 1514395 |
| Report Source | 01,05 |
| Date Received | 2009-10-23 |
| Date of Report | 2009-09-30 |
| Date of Event | 2009-09-25 |
| Date Mfgr Received | 2009-09-30 |
| Date Added to Maude | 2009-10-26 |
| 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 Postal Code | 33773 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TINA SYSTEM 1000 MACHINEUSED - EXCELLENT CONDITION |
| Generic Name | SYSTEM, DIALYSATE DELIVERY, SINGLE PATIENT |
| Product Code | FKP |
| Date Received | 2009-10-23 |
| Catalog Number | SYS1000-L3PE//A09 |
| Operator | NURSE |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE - LARGO |
| Manufacturer Address | 7511 114TH AVE. NORTH LARGO FL 33773 US 33773 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-10-23 |