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*.
[2071209]
This complaint originated as a result of the baxter renal clinical helpline medical information specialist calling corporate product surveillance (b)(4) 2009 to relay a report from a customer, received by voice mail the same day for one (1) ct-190g cellulose triacetate , product code 5m1546, lot number unknown, of which customer caller stated she had questions about a ct-190 dialyzer concerning a patient incident today ((b)(6) 2009). No further information is available at this time. On (b)(6) 2009, product surveillance spoke to the nurse about this incident. She stated that this was not a complaint against the dialyzer, there were no problems with the dialyzer. She had a question regarding the incorrect setup of the dialyzer and bloodline when she spoke to the baxter renal clinical helpline medical information specialist (mis). She stated that the incorrect setup of the bloodline to the dialyzer was a human error by the technician. The technician had attached the arterial bloodline to the venous port on the dialyzer with the patient hooked up. The therapy was run for an hour in this setup with the patient. The charge nurse then noticed that the setup was incorrect, stopped the therapy, reversed the bloodline, connected it properly and resumed therapy with the patient. The patient continued therapy with no problems. There was no patient injury or medical intervention reported with this incident. The patient is okay. There is no problem with the dialyzer.
Patient Sequence No: 1, Text Type: D, B5
[9155168]
(b)(4). This incident was determined to be caused by use/user error and there was no allegation of a product malfunction. Therefore a batch review and sample evaluation will not be conducted. 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 | 1423500-2011-08178 |
| MDR Report Key | 2137217 |
| Report Source | 05 |
| Date Received | 2011-06-22 |
| Date of Report | 2009-06-10 |
| Date of Event | 2009-06-10 |
| Date Mfgr Received | 2009-06-10 |
| 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 | 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 | 2011-06-22 |
| Catalog Number | 5M1546 |
| 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 |