MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-07-02 for U1105 S1000 TINA HD WITH NIBP SYS1000L3P manufactured by Baxter Healthcare - Largo.
[1230547]
A customer contacted a baxter technical service representative (tsr) regarding a tina hemodialysis instrument. The bio-med reported that the instrument has a burnt smell and smoke in the back of the machine. No patient injury and no medical intervention were reported. During a follow up call in 2009, a technician at the facility stated that the smoke could be smelled and was visible a little. He stated that the event date was a few days earlier. This occurred after patient use. The patient had finished the treatment and was disconnected from the machine. There was no medical intervention or hospitalization as a result of this incident. The patient was fine. The instrument is awaiting repair at this time.
Patient Sequence No: 1, Text Type: D, B5
[8309274]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423500-2009-00307 |
| MDR Report Key | 1476268 |
| Report Source | 05 |
| Date Received | 2009-07-02 |
| Date of Report | 2009-06-30 |
| Date of Event | 2009-06-29 |
| Date Mfgr Received | 2009-06-30 |
| Date Added to Maude | 2009-12-30 |
| 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 RT. 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 | U1105 S1000 TINA HD WITH NIBP |
| Generic Name | 78FKP |
| Product Code | FKP |
| Date Received | 2009-07-02 |
| Catalog Number | SYS1000L3P |
| 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 | 2009-07-02 |