MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-06-22 for CT 5M1546 manufactured by Nipro Corporation *usd*.
[2016897]
A dialysis technician reported to baxter a dialyzer that turned grey in color. A follow up was done via phone. The administrator stated that when the blood hit the dialyzer, that is when it turned grey in color, at the very beginning of the setup. There was no medical intervention or hospitalization as a result of this incident. The patient resumed therapy with a new dialyzer and was okay.
Patient Sequence No: 1, Text Type: D, B5
[9168636]
(b)(4). The sample was received and evaluated. The dialyzer was visually inspected by the hemolab and no discoloration was noted. Therefore, this complaint could not be verified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423500-2011-08098 |
| MDR Report Key | 2136507 |
| Report Source | 05 |
| Date Received | 2011-06-22 |
| Date of Report | 2010-03-29 |
| Date of Event | 2010-03-26 |
| Date Mfgr Received | 2010-03-29 |
| Date Added to Maude | 2011-10-27 |
| 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 | VIRGINIA MCKINNEY |
| Manufacturer Street | 25212 W. ILLINOIS ROUTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 8472702835 |
| Manufacturer G1 | NIPRO CORPORATION *USD* |
| Manufacturer Street | 8-7 HANUKI-YACHI, NIIDA-AZA |
| Manufacturer City | OHDATE-SHI |
| Manufacturer Country | JA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CT |
| Generic Name | HEMODIALYZER, RE-USE, HIGH FLUX |
| Product Code | MSF |
| Date Received | 2011-06-22 |
| Returned To Mfg | 2010-04-15 |
| Catalog Number | 5M1546 |
| Lot Number | 09I07DX |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NIPRO CORPORATION *USD* |
| Manufacturer Address | 8-7 HANUKI-YACHI, NIIDA-AZA OHDATE-SHI JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-06-22 |