MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2011-06-22 for CA-HP 5M2733 manufactured by Nipro Corporation *usd*.
[17197116]
A customer reported to baxter (b)(4) that five units of cahp-130 dialyzer were noted leak or blood leak with alarm only after two or three times of reprocessing, which much less normal reuse times (normal reuse 10 times).
Patient Sequence No: 1, Text Type: D, B5
[17313728]
(b)(4). The sample was received and evaluated. Upon visual inspection no obvious defects were found. Then performed manual leak test and observed pressure decay of greater than 10 mmhg per 60 seconds. Further testing was done with manual bubble point test per same sop. Pressure dropped to zero and bubbles were sighted at the venous header and coming out of the dialysate port. This confirms the complaint. 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 | 1423500-2011-07999 |
| MDR Report Key | 2136792 |
| Report Source | 01,05 |
| Date Received | 2011-06-22 |
| Date of Report | 2008-12-10 |
| Date of Event | 2008-12-10 |
| Date Mfgr Received | 2009-01-28 |
| 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 | 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 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 | 2011-06-22 |
| Returned To Mfg | 2009-01-06 |
| Catalog Number | 5M2733 |
| Lot Number | 08B25B |
| 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 *USD* |
| Manufacturer Address | JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-06-22 |