MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-06 for ADSORBA 115263 manufactured by Baxter Healthcare - Hechingen Baden Dialyzer.
[110715713]
(b)(6). The actual samples were not available; however, photographs of the samples were provided for evaluation. During visual inspection of the provided photos, black particles in the tubing and in the header cap of the dialyzer were visible for both samples. The reported condition was verified. The cause of the condition was not determined. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[110715714]
It was reported that black particles were observed in the priming solution of two (2) adsorba 150 c during priming. The dialyzers had been primed with 5% glucose solution and 0. 9% saline solution. There was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611369-2018-00058 |
| MDR Report Key | 7575015 |
| Date Received | 2018-06-06 |
| Date of Report | 2018-07-07 |
| Date of Event | 2018-05-03 |
| Date Mfgr Received | 2018-07-03 |
| Device Manufacturer Date | 2017-07-31 |
| Date Added to Maude | 2018-06-06 |
| 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 | 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 | 0 |
| Brand Name | ADSORBA |
| Generic Name | APPARATUS, HEMOPERFUSION, SORBENT |
| Product Code | FLD |
| Date Received | 2018-06-06 |
| Returned To Mfg | 2018-06-21 |
| Model Number | NA |
| Catalog Number | 115263 |
| Lot Number | 7-656 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER |
| Manufacturer Address | HECHINGEN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-06 |