MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-08 for PRISMAFLEX TPE 115315 manufactured by Gambro Industries.
[35694376]
Unknown
Patient Sequence No: 1, Text Type: N, H10
[35694377]
A patient in (b)(6) was treated with therapeutic plasma exchange (tpe) which included a prismaflex tpe2000 set and a prismaflex machine. At the time of treatment start an external blood leak (estimated at 3 ml) was reportedly observed on the tpe2000 set at the connection of the return line. An unknown machine alarm was reportedly generated and treatment was discontinued.
Patient Sequence No: 1, Text Type: D, B5
[38051684]
Additional manufacturer narrative: the return line from the prismaflex tpe2000 ckt set where the leak reportedly occurred has been returned for investigation. Visual inspection of the returned line confirmed the presence of a hole on the line. However, it is unlikely that this defect occurred during our manufacturing process since it would have been detected during our in-process test. The root cause of the reported event remains unknown.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010182-2016-00002 |
| MDR Report Key | 5353553 |
| Date Received | 2016-01-08 |
| Date of Report | 2016-02-10 |
| Date of Event | 2015-11-26 |
| Date Mfgr Received | 2015-12-10 |
| Device Manufacturer Date | 2015-05-20 |
| Date Added to Maude | 2016-01-08 |
| 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 | 2016-01-08 |
| Returned To Mfg | 2016-01-11 |
| Model Number | 115315 |
| Lot Number | 15E2004 |
| Device Expiration Date | 2018-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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. Other | 2016-01-08 |