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.
[112648922]
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
[112648923]
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 | 8010182-2018-00058 |
| MDR Report Key | 7647599 |
| 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 |