MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,08 report with the FDA on 2009-09-25 for U0707 TINA DOUBLE PUMP CE LCD S1000L3TD manufactured by Baxter Healthcare - Largo.
[1249028]
This device and all leads explanted due to infection. This device was replaced with a philos ii sr, in 2009. This device was discarded by the hospital.
Patient Sequence No: 1, Text Type: D, B5
[8364079]
The heater assembly of the device was evaluated in the baxter product analysis lab (pal) for the reported issue of the heater had caught on fire in the machine during night time, when the device was not in use. No patient was connected to the device. The heater that was received by the pal lab is a model they had not seen before. They do not have any record of this kind of heater ever being used. This heater does not have a thermal switch breaker. The heater was checked and it did not show any obvious problems (heater was not shorted). The assignable cause was not determined by engineer. Baxter requires that the dialysis instrument is connected to a gfci (ground fault circuit interrupter) outlet as a precautionary measure. The machine was not connected to a gfci. Returned parts will be scrapped.
Patient Sequence No: 1, Text Type: N, H10
[18582916]
This is a case report, received by baxter reported from a distributor. It was reported to them by their local customer dialysis center. It was reported that a tina hemodialysis machine was found heavily burned by a fire caused by the heating element of the machine in 2009. It was noticed by the nurse. The fire in the machine was during the night, when the device was not in use. No patient was connected to the device. Several components are burned, but are available for investigation. The customer stated that there was no visible smoke coming from machine, in the morning when the nurse first noticed the incident.
Patient Sequence No: 1, Text Type: D, B5
[18697608]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423500-2009-00430 |
| MDR Report Key | 1482854 |
| Report Source | 01,05,08 |
| Date Received | 2009-09-25 |
| Date of Report | 2009-08-31 |
| Date of Event | 2009-08-27 |
| Date Mfgr Received | 2009-10-15 |
| 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 Postal Code | 33773 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | U0707 TINA DOUBLE PUMP CE LCD |
| Generic Name | SYSTEM, DIALYSATE DELIVERY, SINGLE PATIENT |
| Product Code | FKP |
| Date Received | 2009-09-25 |
| Returned To Mfg | 2009-09-13 |
| Catalog Number | S1000L3TD |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2009-09-25 |