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 2017-05-15 for PRISMAFLEX TPE N/A 107144 manufactured by Gambro Industries.
[75209267]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[75209268]
A patient was treated with therapeutic plasma exchange (tpe), using a prismaflex tpe 2000 set and a prismaflex control unit for the first time. About 15 minutes after treatment start, once the first albumin bag had been infused, the patient reportedly became pale and felt unwell. The patient reportedly presented with a significant blood pressure drop to 70/50 mmhg, and their oxygen saturation was at 90% whereas they had no respiratory history. Treatment was discontinued and the patient received a bolus of 100 ml of isotonic saline solution, which led to an increase of blood pressure to 90/50 mmhg 10 minutes later. The physician suspected a hemolysis without back pain. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010182-2017-00030 |
| MDR Report Key | 6568360 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-05-15 |
| Date of Report | 2017-06-22 |
| Date of Event | 2017-04-05 |
| Date Mfgr Received | 2017-05-30 |
| Device Manufacturer Date | 2017-01-01 |
| Date Added to Maude | 2017-05-15 |
| 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 |
| 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 | GAMBRO INDUSTRIES |
| Manufacturer Street | 7 AVENUE LIONEL TERRAY |
| Manufacturer City | MEYZIEU |
| Manufacturer Country | FR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRISMAFLEX TPE |
| Product Code | MDP |
| Date Received | 2017-05-15 |
| Model Number | N/A |
| Catalog Number | 107144 |
| Lot Number | 17A1806 |
| ID Number | N/A |
| Device Expiration Date | 2020-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GAMBRO INDUSTRIES |
| Manufacturer Address | 7 AVENUE LIONEL TERRAY MEYZIEU 69883 FR 69883 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-05-15 |