MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04 report with the FDA on 2010-11-05 for CAHP-150 CELLULOSE DIACETATE DIALYZER 5M2734 manufactured by Nipro Corporation *usd*.
[8924578]
(b)(4). This complaint was confirmed in the lab. The evaluation found that there was leakage at the venous header and bubbling out of the dialysate port. No root cause was identified. A batch review was conducted and no issues were found during the manufacture of the lot. A review of the manufacturing, process inspection and release inspection records was performed and no defects were noted. In addition, testing of the retained samples showed no abnormalities. Renal quality engineering, along with plant manufacturing and quality personnel, will continue to monitor this product line for trends and will take corrective/preventive action as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[21427649]
A customer reported to baxter an incident involving a dialyzer. The customer stated that there was a leak at the fiber at the 4th time of reuse. There was no patient injury or medical intervention reported.
Patient Sequence No: 1, Text Type: D, B5
[21476068]
(b)(4). The device/product sample has been received by baxter; however, the evaluation has not been completed. A follow-up report will be submitted upon completion of the device evaluation, or if any additional information is received.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423500-2010-05299 |
| MDR Report Key | 1891586 |
| Report Source | 01,04 |
| Date Received | 2010-11-05 |
| Date of Report | 2010-10-12 |
| Date of Event | 2010-10-03 |
| Date Mfgr Received | 2010-12-21 |
| Date Added to Maude | 2011-09-30 |
| 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 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 | CAHP-150 CELLULOSE DIACETATE DIALYZER |
| Generic Name | HEMODIALYZER, RE-USE, HIGH FLUX |
| Product Code | MSF |
| Date Received | 2010-11-05 |
| Returned To Mfg | 2010-10-22 |
| Catalog Number | 5M2734 |
| Lot Number | 09G02D |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 0185794 JA 0185794 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-11-05 |