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*.
[2071679]
A customer called baxter to report a blood leak. The leak was at the beginning of treatment. The patient continued therapy with a different dialyzer, the patient went back on with a backup ct190g 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
[9170390]
(b)(4). The sample was discarded. This mdr is being submitted as part of baxter renal's retrospective review & remediation project. This report is being filed late to fulfill baxter's commitment to perform a two year retrospective review of renal complaints in response to fda-warning letter chi-07-10.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 1423500-2011-08184 |
MDR Report Key | 2137240 |
Report Source | 05 |
Date Received | 2011-06-22 |
Date of Report | 2009-03-20 |
Date of Event | 2009-02-16 |
Date Mfgr Received | 2009-03-20 |
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 |
Catalog Number | 5M1546 |
Lot Number | 08C10EX |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | * |
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 |