MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2009-11-13 for U0707 S1000 TINA HD MACHINEREFURB S1000L3PR manufactured by Baxter Healthcare - Largo.
[20349384]
A customer contacted baxter technical service regarding a tina hemodialysis instrument. The home patient (hp) stated that the machine is pulling off too much fluid during patient use. The patient reported two incidences in 2009. On the second day, the machine was programmed to remove one pound of fluid in six hours and the machine removed two pounds of fluid in one hour. He stated he had to terminate treatment both dates and he could not return the blood in the tubing set, so he lost 200-300 cc's. The hp did not restart treatment after these incidents. He stated there was no injury or medical intervention associated with pulling off too much fluid. During follow up, the hp stated that the machine had been failing self-test and that the flow equalizer was malfunctioning. The hp also reported that the dialyzer was clotting off and per the hp this was a result of the flow equalizer issue.
Patient Sequence No: 1, Text Type: D, B5
[20615115]
In 2009, a field service engineer (fse) went to the hp's home, evaluated the device and confirmed the problem. The fse replaced the bypass valve, all valves, the diaphragms, the o-rings on the flow equalizer, and the end of stroke sensors (eos). The fse calibrated the temperature, the conductivity, the ultrafiltration (uf) flow rate, the dialysate flow rate and the dialysate pressure. The fse inspected and tested the machine and all systems passed. The fse ran a mock treatment and checked volume and this was accurate. Machine was released for use by the patient.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423500-2009-00519 |
| MDR Report Key | 1526303 |
| Report Source | 04 |
| Date Received | 2009-11-13 |
| Date of Report | 2009-10-21 |
| Date of Event | 2009-10-21 |
| Date Mfgr Received | 2009-10-23 |
| Date Added to Maude | 2009-12-31 |
| 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 | U0707 S1000 TINA HD MACHINEREFURB |
| Generic Name | SYSTEM, DIALYSATE DELIVERY, SINGLE PATIENT |
| Product Code | FKP |
| Date Received | 2009-11-13 |
| Returned To Mfg | 2009-10-23 |
| Catalog Number | S1000L3PR |
| Lot Number | N/A |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| 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 | 2009-11-13 |