MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-11-20 for CT GAMMA DIALYZER (CT 190G) 5M1546 manufactured by Nipro Corporation.
[995696]
In the middle of the treatment a blood lead was noted. It was confirmed with a positive hemastix test. The dialyzer had 24 reuses. There was no medical intervention.
Patient Sequence No: 1, Text Type: D, B5
[8136542]
The facility uses the renatron reuse system with renalin. The renatron has had periodic maintenance and has been calibrated. Both were performed on schedule. The average number of reuses that the facility is getting with these dialyzers is 24-25. This number has not increased or decreased in recent months. The ro water source psi going into the reuse system is 20 psi for rinsing ct 190 g dialyzers. There is a regulator on the water source going into the reuse system. The facility does pre-process dialyzers and the dialyzers pass leak testing prior to use. Dialyzers are pre-rinsed before they are placed on the renatron and there is a regulator o this water source. It is the same water. There are two lines and two regulators. The facility has been using the ct 190g dialyzers for 4 years. 95% of the patients at this facility use the ct 190g dialyzers. A follow-up report will be submitted following the completion of the device evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423500-2007-00010 |
| MDR Report Key | 1236548 |
| Report Source | 05 |
| Date Received | 2008-11-20 |
| Date of Report | 2006-12-13 |
| Date of Event | 2006-12-12 |
| Date Mfgr Received | 2006-12-13 |
| Date Added to Maude | 2008-11-20 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KAREN KIRBY |
| Manufacturer Street | ROUTE 120 & WILSON ROAD |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 8472704541 |
| Manufacturer G1 | NIPRO CORPORATION |
| Manufacturer Street | 8-7, HANUKI-YACHI, NIIDA-AZA |
| Manufacturer City | OHDATE-SHI, AKITA 0185794 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 0185794 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CT GAMMA DIALYZER (CT 190G) |
| Generic Name | HOLLOW FIBER DIALYZER |
| Product Code | MSF |
| Date Received | 2008-11-20 |
| Returned To Mfg | 2006-12-21 |
| Model Number | CT 190G |
| Catalog Number | 5M1546 |
| Lot Number | 06F26DX |
| ID Number | NA |
| Device Expiration Date | 2009-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1288482 |
| Manufacturer | NIPRO CORPORATION |
| Manufacturer Address | OHDATE-SHI, AKITA JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-11-20 |