MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-21 for PRISMAFLEX TPE 107144 manufactured by Gambro Industries.
[55325580]
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Patient Sequence No: 1, Text Type: N, H10
[55325581]
A patient in (b)(6) was undergoing a tpe treatment. Fifteen minutes into treatment and prior to the infusion of albumin, the patient experienced a blood pressure drop, diaphoresis, pallor, oxygen desaturation to 88% followed by severe and intense low back pain. Treatment was discontinued and the blood was returned to the patient. The patient received 300 ml of saline solution, 1g of paracetamol, oxygen @ 2 l/min and inhalation of salbutamol 5 mg. The back pain reportedly lasted for 15 to 20 minutes despite the administration of analgesic drugs. The patient recovered after the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010182-2016-00074 |
| MDR Report Key | 5967937 |
| Date Received | 2016-09-21 |
| Date of Report | 2016-09-21 |
| Date of Event | 2016-08-17 |
| Date Mfgr Received | 2016-08-26 |
| Device Manufacturer Date | 2016-05-01 |
| Date Added to Maude | 2016-09-21 |
| 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 | 0 |
| Brand Name | PRISMAFLEX TPE |
| Product Code | MDP |
| Date Received | 2016-09-21 |
| Model Number | 107144 |
| Lot Number | 16E2007A |
| 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 | 2016-09-21 |