MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-05-10 for PRISMAFLEX TPE 107144 manufactured by Gambro Industries.
[44861414]
Unknown.
Patient Sequence No: 1, Text Type: N, H10
[44861415]
A patient in (b)(6) who was undergoing a therapeutic plasma exchange (tpe) treatment. Approximately 15 minutes into the treatment, the patient developed pain in the lower abdomen and trembling legs. The patient was administered 2 ampules of spasfon (phloroglucinol, trimethylphloroglucinol) and 1 gr of doliprane (paracetamol). Treatment was discontinued without returning the blood in the extracorporeal circuit resulting in an estimated blood loss of 125 ml. The treatment was restarted later.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010182-2016-00035 |
| MDR Report Key | 5644602 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-05-10 |
| Date of Report | 2016-05-10 |
| Date of Event | 2016-02-08 |
| Date Mfgr Received | 2016-04-13 |
| Device Manufacturer Date | 2016-01-07 |
| Date Added to Maude | 2016-05-10 |
| 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 Contact | THIERRY PALKOVICS |
| Manufacturer Street | 7 AVENUE LIONEL TERRAY |
| Manufacturer City | MEYZIEU |
| Manufacturer Country | FR |
| Manufacturer Phone | 472452525 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRISMAFLEX TPE |
| Product Code | MDP |
| Date Received | 2016-05-10 |
| Model Number | 107144 |
| Lot Number | 16A0702 |
| Device Expiration Date | 2019-01-01 |
| 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 | 2016-05-10 |