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 2020-03-26 for POLYFLUX 140H 112465 manufactured by Baxter Healthcare - Hechingen Baden Dialyzer.
[185104547]
(b)(6). The sample was not returned and the lot number of the device was unknown; therefore, a sample analysis could not be completed. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[185104548]
It was reported during treatment with a polyflux 140h dialyzer, a blood leak was observed. The source of the leak was unknown. There was no patient injury or medical intervention associated with this event. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611369-2020-00027 |
| MDR Report Key | 9884377 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date Mfgr Received | 2020-03-02 |
| Date Added to Maude | 2020-03-26 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | POLYFLUX 140H |
| Generic Name | DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM |
| Product Code | KDI |
| Date Received | 2020-03-26 |
| Model Number | NA |
| Catalog Number | 112465 |
| Lot Number | 9-5819-H-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-03-26 |