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 2017-07-11 for PRISMAFLEX TPE N/A 107144 manufactured by Gambro Industries.
[79655408]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[79655409]
A patient was treated with therapeutic plasma exchange (tpe) for the first time. The therapy was started using a prismaflex tpe 2000 set (which had been primed using 3 liters of saline) and a prismaflex control unit, as well as 4% albumin as replacement solution. Anticoagulation was achieved using 200 units of heparin as a loading dose then infusion of 500 units/hour. Blood flow was set at 300ml/min, and the replacement of 3. 6l of plasma was planned. Thirty minutes into treatment, during the infusion of the first bag of 4% albumin, the patient presented with hypotension, nausea, vomiting, chills and lower back pains. Due to this event, the plasma removal and the infusion of 4% albumin was stopped (blood was still circulating in the prismaflex tpe 2000 set), and the patient received 100 ml of saline solution and 50 mg of tramadol. Around 10 minutes after the apparition of the symptoms, the patient started feeling better. An electrocardiogram (ecg) was performed which showed a right branch block. Tpe treatment was then discontinued, and the patient was addressed to a cardiologist (outcome not reported). No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010182-2017-00047 |
| MDR Report Key | 6702480 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-07-11 |
| Date of Report | 2017-07-11 |
| Date of Event | 2017-03-25 |
| Date Mfgr Received | 2017-06-20 |
| Device Manufacturer Date | 2016-10-01 |
| Date Added to Maude | 2017-07-11 |
| 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 | 2017-07-11 |
| Model Number | N/A |
| Catalog Number | 107144 |
| Lot Number | 16J0604 |
| ID Number | N/A |
| Device Expiration Date | 2019-10-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2017-07-11 |