MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04 report with the FDA on 2011-06-20 for CA-HP 5M2734 manufactured by Nipro Corporation.
[20382667]
(b)(4). The sample was received and evaluated. This complaint was confirmed in the lab for a leak via bubble point testing for leaks coming out of the venous header and out the dialysate port. The root cause is undetermined. Baxter has conducted a trend review and found that similar reports have been received for the reported problem. Baxter will continue to monitor similar reports to determine if further actions are required. A batch review was conducted and no issues were found related to the reported condition during the manufacture of the lot. 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 (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[20415801]
After one minute of patient treatment, the the device alarmed with a blood leak. Treatment resumed and ran normally after a new dialyzer used. This incident occurred on the second use of the dialyzer. No patient injury or medical intervention was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423500-2011-07975 |
| MDR Report Key | 2134685 |
| Report Source | 01,04 |
| Date Received | 2011-06-20 |
| Date of Report | 2009-06-22 |
| Date of Event | 2009-06-22 |
| Date Mfgr Received | 2009-06-23 |
| Device Manufacturer Date | 2008-04-29 |
| Date Added to Maude | 2011-10-27 |
| 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 | 8472702835 |
| Manufacturer G1 | NIPRO CORPORATION USD |
| Manufacturer City | OHIDATE-SHI |
| Manufacturer Country | JA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CA-HP |
| Generic Name | HEMODIALYZER, RE-USE, HIGH FLUX |
| Product Code | MSF |
| Date Received | 2011-06-20 |
| Returned To Mfg | 2009-06-30 |
| Catalog Number | 5M2734 |
| Lot Number | 08B26C |
| Device Expiration Date | 2011-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NIPRO CORPORATION |
| Manufacturer Address | OHDATE-SHI JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-06-20 |