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 2018-03-15 for PRISMAFLEX 107144 manufactured by Baxter Healthcare - Meyzieu.
[102514013]
(b)(6). Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[102514014]
During treatment of a patient with a prismaflex tpe2000 set, during the infusion of the first fresh frozen plasma bag, the patient had severe lumbar pain (visual analogue scale pain at 10/10), that radiated to the hips and buttocks. Exchange was interrupted for 25 minutes, and the patient received 1 g of paracetamol and 3 mg of morphine (route of administration not reported). The outcome of the patient was not reported. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010182-2018-00016 |
| MDR Report Key | 7342217 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-03-15 |
| Date of Report | 2018-04-19 |
| Date of Event | 2018-02-09 |
| Date Mfgr Received | 2018-03-26 |
| Device Manufacturer Date | 2017-06-01 |
| Date Added to Maude | 2018-03-15 |
| 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 |
| Generic Name | SEPARATOR FOR THERAPEUTIC PURPOSES, MEMBRANE AUTOMATED BLOOD CELL/PLASMA |
| Product Code | MDP |
| Date Received | 2018-03-15 |
| Model Number | NA |
| Catalog Number | 107144 |
| Lot Number | 17F1406 |
| 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 CEDEX RHONE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-03-15 |