MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-20 for REVACLEAR 500 955543 manufactured by Baxter Healthcare - Hechingen Baden Dialyzer.
[185296692]
(b)(6). The device was received for evaluation. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. Visual inspection with the naked eye showed a black contamination located in the area of the o-ring sealing in the header. The reported condition was verified. A nonconformance has been opened to address this issue. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[185296693]
It was reported that before use with a revaclear 500, a black mark on one side of the dialyzer was observed inside the dialyzer. There was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611369-2020-00023 |
| MDR Report Key | 9860338 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-20 |
| Date of Event | 2020-02-26 |
| Date Mfgr Received | 2020-02-26 |
| Date Added to Maude | 2020-03-20 |
| 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 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 25212 W. ILLINOIS ROUTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 2242702068 |
| Manufacturer G1 | BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER |
| Manufacturer Street | HOLGER - CRAFOORD - STRASSE 26 |
| Manufacturer City | HECHINGEN D-72379 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-72379 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REVACLEAR 500 |
| Generic Name | DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM |
| Product Code | KDI |
| Date Received | 2020-03-20 |
| Returned To Mfg | 2020-03-05 |
| Model Number | NA |
| Catalog Number | 955543 |
| Lot Number | 0-7300-H-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER |
| Manufacturer Address | DEERFIELD IL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-20 |