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 2019-05-09 for PRISMAFLEX TPE 115314 manufactured by Baxter Healthcare - Meyzieu.
[145654351]
Facility name: (b)(6). Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[145654352]
It was reported that during treatment with a prismaflex tpe1000 set, an internal blood leakage was observed. It was reported "reddish effluent fluid/bag was found by naked eyes". 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 | 8010182-2019-00118 |
MDR Report Key | 8596742 |
Report Source | COMPANY REPRESENTATIVE,FOREIG |
Date Received | 2019-05-09 |
Date of Report | 2019-06-10 |
Date of Event | 2019-04-08 |
Date Mfgr Received | 2019-06-04 |
Device Manufacturer Date | 2018-01-01 |
Date Added to Maude | 2019-05-09 |
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 - MEYZIEU |
Manufacturer Street | 7, AV LIONEL TERRAY, B.P. 126 |
Manufacturer City | MEYZIEU 69883 |
Manufacturer Country | FR |
Manufacturer Postal Code | 69883 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | PRISMAFLEX TPE |
Generic Name | SEPARATOR FOR THERAPEUTIC PURPOSES, MEMBRANE AUTOMATED BLOOD CELL/PLASMA |
Product Code | MDP |
Date Received | 2019-05-09 |
Model Number | NA |
Catalog Number | 115314 |
Lot Number | 18A1102A |
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 - MEYZIEU |
Manufacturer Address | MEYZIEU |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2019-05-09 |