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 2019-01-31 for ADSORBA 150C 115263 manufactured by Baxter Healthcare - Hechingen Baden Dialyzer.
[136986459]
(b)(6). Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[136986460]
It was reported that during priming of an adsorba 150 c unit, foreign matter was observed. The set was replaced. There was no patient involvement with the reported event. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 9611369-2019-00009 |
MDR Report Key | 8294989 |
Report Source | COMPANY REPRESENTATIVE,FOREIG |
Date Received | 2019-01-31 |
Date of Report | 2019-02-22 |
Date of Event | 2019-01-01 |
Date Mfgr Received | 2019-02-12 |
Date Added to Maude | 2019-01-31 |
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 | 3 |
Brand Name | ADSORBA 150C |
Generic Name | APPARATUS, HEMOPERFUSION, SORBENT |
Product Code | FLD |
Date Received | 2019-01-31 |
Model Number | NA |
Catalog Number | 115263 |
Lot Number | 7-658 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Age | DA |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER |
Manufacturer Address | HECHINGEN |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2019-01-31 |