MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2011-06-20 for CA-HP 5M2733 manufactured by Nipro Corporation Usd.
[15142295]
A nurse reported to baxter (b)(4) that seven units of blood leaked during patient use between the second and third uses of the device. A leak alarm occurred first and then it was noted that blood was leaking out. No patient injury or medical intervention was reported along with this complaint.
Patient Sequence No: 1, Text Type: D, B5
[15170952]
(b)(4). Sample was not available for evaluation; therefore, the root cause is undetermined. A batch review was conducted and no issues were found related to the reported condition during the manufacture of the lot. 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. 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 | 1423500-2011-07838 |
| MDR Report Key | 2133796 |
| Report Source | 01,05 |
| Date Received | 2011-06-20 |
| Date of Report | 2010-01-19 |
| Date of Event | 2009-12-21 |
| Date Mfgr Received | 2010-01-20 |
| Date Added to Maude | 2012-02-09 |
| 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 0185794 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 0185794 |
| 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 |
| Catalog Number | 5M2733 |
| Lot Number | 09G18C |
| 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 0185794 JA 0185794 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-06-20 |