MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2010-09-29 for CAHP-150 CELLULOSE DIACETATE DIALYZER 5M2734 manufactured by Nipro Corporation Usd.
[1478884]
Baxter (b)(4) received a report that a dialyzer leaked during the prefilling stage from the 1st to the 2nd reuse of the product. No patient injury or medical intervention was reported. No further information is available.
Patient Sequence No: 1, Text Type: D, B5
[8706424]
(b)(4). A sample is not available for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[8890120]
(b)(4). There were no samples or pictures available to evaluate the issue. Therefore, a root cause cannot be determined. A review of the manufacturing, process inspection and release inspection records was performed for the lot involved (09i30a) and no defects were noted. In addition, testing of the retained samples showed no abnormalities. Similar reports have been received for the reported problem. Baxter will continue to monitor similar reports to determine if further actions are required.
Patient Sequence No: 1, Text Type: N, H10
[8898529]
(b)(4). Information obtained from the international affiliate indicates that the leak occurred at the dialyzer fibers. Therefore, this event has been determined to be non-reportable.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423500-2010-03829 |
| MDR Report Key | 1847873 |
| Report Source | 01,05 |
| Date Received | 2010-09-29 |
| Date of Report | 2010-08-04 |
| Date of Event | 2010-08-02 |
| Date Mfgr Received | 2010-10-27 |
| Date Added to Maude | 2011-05-19 |
| 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 | 2010-09-29 |
| Catalog Number | 5M2734 |
| Lot Number | 09I30A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2010-09-29 |