MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-12-22 for PRISMAFLEX TPE 107144 manufactured by Gambro Industries.
[63187402]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[63187403]
A patient in (b)(6) was undergoing therapeutic plasma exchange (tpe) with a prismaflex tpe 2000 set. Prior to starting treatment , the prismaflex tpe2000 set was primed with isotrope saline solution and heparin was used as anticoagulation. The patient's blood pressure was 200/94 and pulse 65 bpm at the start of treatment. During treatment, after the replacement of 220 ml plasma with albumin 4 %, the patient experienced intense low back pain. Reportedly, the patient felt pain from the ears to the feet, and it felt like an? Electrical shock? Making it impossible for her to stay in lying position. The replacement flow rate was stopped and the patient was given 1 g paracetamol, 5 mg oxynormoro and 500 mg solumedrol. The treatment was discontinued without returning the blood n the circuit to the patient. Following this event the next six treatments were immunoadsorption sessions.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010182-2016-00095 |
| MDR Report Key | 6201672 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-12-22 |
| Date of Report | 2016-12-22 |
| Date of Event | 2016-11-14 |
| Date Mfgr Received | 2016-12-01 |
| Device Manufacturer Date | 2016-05-01 |
| Date Added to Maude | 2016-12-22 |
| 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 | 2249487578 |
| 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 | 2016-12-22 |
| Model Number | 107144 |
| Lot Number | 16E1207A |
| Device Expiration Date | 2019-05-01 |
| 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 | 2016-12-22 |