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*.
[22128238]
This complaint originated as a result of the reuse technician, calling baxter to report a ct-190g reusable dialyzer, model 5m1546, lot number 08j13cx having a blood leak. The event date was (b)(6) 2009 with 28 reuses of the dialyzer. The leak was at the beginning of treatment. The patient continued therapy with a new single use dialyzer and was okay. There was no patient injury and no medical intervention reported, the patient is doing fine.
Patient Sequence No: 1, Text Type: D, B5
[22256938]
(b)(4). The sample was available and requested. A disinfection procedure was performed to remove the blood. All the blood was unable to be removed; therefore, no further procedural tests were performed. There was residual blood which stained the end of the fibers in the venous header from the many uses. No blood clots were found. Visual inspection was performed and no obvious defects were found. See photo in the above evaluation attachment. This dialyzer is biohazardous and no other testing can be performed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423500-2011-08107 |
| MDR Report Key | 2136753 |
| Report Source | 05 |
| Date Received | 2011-06-22 |
| Date of Report | 2009-03-20 |
| Date of Event | 2009-03-20 |
| Date Mfgr Received | 2009-04-10 |
| Date Added to Maude | 2012-02-13 |
| 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 | 0 |
| 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 | 8472704541 |
| 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 | 2009-04-08 |
| Catalog Number | 5M1546 |
| Lot Number | 08J13CX |
| Device Expiration Date | 2011-09-30 |
| Operator | OTHER |
| 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 |