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*.
[16744133]
A customer contacted baxter to report a dialyzer with a blood leak. She stated that the patient was using the ct190g dialyzer, that there was a blood leak during the patient's treatment with the dialyzer and that the event was resolved. There was no patient injury or medical intervention reported with this incident.
Patient Sequence No: 1, Text Type: D, B5
[17042040]
(b)(4). The sample was received and evaluated. Disinfection procedure was performed but all the blood was unable to be removed from the dialyzer. A visual inspection was performed and no other obvious defects were found. A batch review was performed by the supplier and no abnormalities were found within the batch. Renal product surveillance and quality engineering will continue to monitor this product family for adverse trends and will take corrective/preventive actions, as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423500-2011-08169 |
| MDR Report Key | 2137179 |
| Report Source | 05 |
| Date Received | 2011-06-22 |
| Date of Report | 2009-05-05 |
| Date of Event | 2009-05-03 |
| Date Mfgr Received | 2009-05-03 |
| Date Added to Maude | 2012-02-10 |
| 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 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 | 2009-05-08 |
| Catalog Number | 5M1546 |
| Lot Number | 08C10EX |
| 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 |