MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-04 for PRISMAFLEX TPE 2000 SET 114093 manufactured by Gambro Industries.
[93584372]
Patient Sequence No: 1, Text Type: N, H10
[93584373]
Per report: 25 minutes after initiating albumin plasmapharesis, patient complained of shortness of air and nausea - heart rate: 49, blood pressure:107/54. Doctor at bedside asked if allergic reaction to filter. O2 saturation: 85%. As soon as blood returned, patient symptoms subsided. Heart rate up to 73. Blood pressure: 157/58 and sao2 up to 93%.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7078487 |
| MDR Report Key | 7078487 |
| Date Received | 2017-12-04 |
| Date of Report | 2017-11-29 |
| Date of Event | 2017-11-28 |
| Report Date | 2017-11-29 |
| Date Reported to FDA | 2017-11-29 |
| Date Reported to Mfgr | 2017-11-29 |
| Date Added to Maude | 2017-12-04 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRISMAFLEX TPE 2000 SET |
| Generic Name | SEPARATOR FOR THERAPEUTIC PURPOSES, MEMBRANE AUTOMATED BLOOD CELL/PLASMA |
| Product Code | MDP |
| Date Received | 2017-12-04 |
| Model Number | 114093 |
| Catalog Number | 114093 |
| Lot Number | 17H2201A |
| ID Number | 7676172713044900/10000014002 |
| Device Availability | * |
| Device Age | 0 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GAMBRO INDUSTRIES |
| Manufacturer Address | 9540 MAROON CIR FL 4 ENGLEWOOD CO 80112 US 80112 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-04 |