MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2009-05-27 for U0707 S1000 TINA HD MACHINEREFURB S1000L3PR manufactured by Baxter Healthcare.
[1159290]
In 2009, a patient contacted baxter technical service regarding a tina hemodialysis instrument that was in the patient's home. The home patient (hp) stated that the instrument was taking off too much fluid during patient use. No patient injury and no medical intervention were reported. A field service engineer (fse) went to the home of the hp and replaced the leaking flow equalizer valve. The fse inspected and tested the machine. At approx 6-weeks later, product surveillance spoke to the hp about this incident of the instrument was taking off too much fluid during patient use. He stated that he was about 3/4 of the way through the treatment when he began to experience right leg cramps and noted that he was dehydrated, therefore, he administered 1 liter of saline to resolve those issues. The patient stated that was when he noted the blood clotting off of the kidney, which was when the patient noticed too much fluid being removed (the patient explained that he meant the dialyzer was clotted off) but because he had terminated the therapy, he did not need to replace the dialyzer at that time. The patient stated the fse came out, evaluated and repaired the tina. The patient stated he resumed treatment 2 days later after the machine was repaired and has had no further issues. The patient stated he used a scale to calculate the amount of fluid required. The treatment was programmed for 6 hours. The treatment actually lasted about 4 hours. The weight to be removed was 1 kilo and took off about 3 kilos. The dialyzer used was a exeltra 210 (baxter dialyzer).
Patient Sequence No: 1, Text Type: D, B5
[8144193]
An on site visit was made to the patient's home by the field service engineer. The device was evaluated and repaired. A leaking flow equalizer valve was replaced.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423500-2009-00248 |
| MDR Report Key | 1395550 |
| Report Source | 04 |
| Date Received | 2009-05-27 |
| Date of Report | 2009-04-01 |
| Date of Event | 2009-04-01 |
| Date Mfgr Received | 2009-05-14 |
| Date Added to Maude | 2009-06-02 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KAREN KIRBY |
| Manufacturer Street | 25212 W. ILLINOIS ROUTE 120 |
| Manufacturer City | ROUNDA 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 | 78FKP |
| Product Code | FKP |
| Date Received | 2009-05-27 |
| Catalog Number | S1000L3PR |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE |
| Manufacturer Address | LARGO FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-05-27 |