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 2018-06-28 for PRISMAFLEX TPE 107144 manufactured by Baxter Healthcare - Meyzieu.
[112704077]
The device was not returned and the lot number is unknown; therefore, a device 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
[112704078]
It was reported that a patient undergoing a therapeutic plasma exchange (tpe) treatment with a prismaflex tpe set and a prismaflex control unit experienced generalized hives, respiratory problems and was hospitalized. Albumin and/or fresh frozen plasma were used during the tpe treatment. There was no medical intervention reported for this event and the reporter declined to provide additional information.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 8010182-2018-00059 |
MDR Report Key | 7647704 |
Report Source | COMPANY REPRESENTATIVE,FOREIG |
Date Received | 2018-06-28 |
Date of Report | 2018-06-28 |
Date Mfgr Received | 2018-06-01 |
Date Added to Maude | 2018-06-28 |
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 CEDEX RHONE 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 | 2018-06-28 |
Model Number | NA |
Catalog Number | 107144 |
Lot Number | ASKU |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | BAXTER HEALTHCARE - MEYZIEU |
Manufacturer Address | MEYZIEU CEDEX RHONE |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Hospitalization | 2018-06-28 |