MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04 report with the FDA on 2011-06-20 for CT 5M1546 manufactured by Nipro Corporation *usd*.
[2033818]
A customer reported to baxter (b)(4) that the dialyzer fail the test. It can not pass during the second time reused. No patient injury or medical intervention was reported along with this complaint.
Patient Sequence No: 1, Text Type: D, B5
[9015574]
(b)(4). The sample was received and evaluated. A visual inspection was performed on each and no obvious defects were found. A manual bubble point test was performed on each dialyzer and leakage at the venous header and bubbles flowed out the dialysate port. This confirms the complaint.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423500-2011-07971 |
| MDR Report Key | 2134673 |
| Report Source | 01,04 |
| Date Received | 2011-06-20 |
| Date of Report | 2010-07-07 |
| Date of Event | 2010-05-03 |
| Date Mfgr Received | 2010-07-16 |
| 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 |
| Reporter Occupation | PATIENT |
| 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 | 2011-06-20 |
| Returned To Mfg | 2010-07-12 |
| Catalog Number | 5M1546 |
| Lot Number | 09H03DX |
| Device Expiration Date | 2012-07-31 |
| 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 | 2011-06-20 |