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 2019-03-28 for PRISMAFLEX TPE 107144 manufactured by Baxter Healthcare - Meyzieu.
[140188714]
Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[140188715]
It was reported that after starting plasmapheresis treatment using a prismaflex tpe set, the patient experienced chest tightness and tachycardia. The events occurred approximately 10 min after the albumin infusion. It was reported this was the fourth session of plasmapheresis, and no issues reported during the first three sessions. Treatment was discontinued and the extracorporeal blood was returned to the patient. The patient received a treatment of polarmine (no further details) and the symptoms? Disappeared? After 30 minutes. It was reported a new session was performed the following day. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010182-2019-00084 |
| MDR Report Key | 8460662 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-03-28 |
| Date of Report | 2019-05-01 |
| Date of Event | 2019-01-17 |
| Date Mfgr Received | 2019-04-08 |
| Date Added to Maude | 2019-03-28 |
| 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 |
| Reporter Occupation | PHARMACIST |
| 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 | 2019-03-28 |
| Model Number | NA |
| Catalog Number | 107144 |
| Lot Number | 18G1203 |
| 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. Required No Informationntervention | 2019-03-28 |