MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04,07 report with the FDA on 2011-06-29 for CT 5M1546 manufactured by Nipro Corporation *usd*.
[2075021]
A dialysis technician reported to baxter that there was a blood leak in a dialyzer. A follow up was done via phone. The assistant administrator stated, the blood leak was from the header of the dialyzer at the venous end. The blood leak occurred during the early middle part of the treatment. It was discovered by a blood leak alarm on the machine. It was confirmed twice by a hemastix test. The estimated blood loss to the patient was 150 to 250 mls. There was no medical intervention or hospitalization as a result of this incident. The patient resumed therapy with a new dialyzer and was okay.
Patient Sequence No: 1, Text Type: D, B5
[9191030]
(b)(4). The sample was received and evaluated. Upon visual inspection no defects were observed. A leak test was performed and bubbles were observed coming from the fibers and out the arterial and venous dialysate ports. This confirms the complaint. The root cause was not determined. 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 (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423500-2011-08465 |
| MDR Report Key | 2143322 |
| Report Source | 01,04,07 |
| Date Received | 2011-06-29 |
| Date of Report | 2010-03-23 |
| Date of Event | 2010-03-22 |
| Date Mfgr Received | 2010-03-23 |
| Date Added to Maude | 2011-10-28 |
| 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 | 2011-06-29 |
| Returned To Mfg | 2010-04-08 |
| Catalog Number | 5M1546 |
| Lot Number | 09I07DX |
| Operator | HOSPITAL SERVICE TECHNICIAN |
| 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 | 2011-06-29 |