MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-03-24 for PRISMAFLEX TPE 114093 manufactured by Gambro Industries.
[41118299]
Patient Sequence No: 1, Text Type: N, H10
[41118300]
A patient with goodpasture syndrome was prescribed tpe treatments. Reportedly, 2 to 4 prismaflex tpe 2000 sets clotted for each treatment. When the sets clotted, the patient's blood was returned "most of the time". They attempted anticoagulation but it did not help the clotting filters. The patient received one unit of packed red blood cells when his hemoglobin dropped to 7. 2 g/dl.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010182-2016-00022 |
| MDR Report Key | 5523768 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-03-24 |
| Date of Report | 2016-03-24 |
| Date of Event | 2016-02-24 |
| Date Facility Aware | 2016-02-24 |
| Report Date | 2016-03-24 |
| Date Reported to FDA | 2016-03-24 |
| Date Reported to Mfgr | 2016-03-24 |
| Date Mfgr Received | 2016-02-24 |
| Date Added to Maude | 2016-03-24 |
| 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 | 2016-03-24 |
| Model Number | 114093 |
| Lot Number | NOT PROVIDED |
| 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 | 2016-03-24 |