MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-11-08 for PRISMAFLEX * manufactured by Gambro Renal Products, Inc..
[15539636]
Patient needed a new filter set-up due to last set going down from air in lines. Patient was placed on the continuous renal replacement therapy (crrt) machine. About ten minutes after crrt machine was started, patient's bp decreased without response to norepinephrine. Patient's hr decreased and oxygen saturation dropped as well, and pt coded. Cpr was performed, two ampules of epinephrine were given. Patient's heart activity, bp and oxygen saturation returned. Patient's neuro status returned back to previous state before code. Patient was sedated and is currently still sedated. Patient's ionized calcium came back as 1. 12.
Patient Sequence No: 1, Text Type: D, B5
[15555769]
Patient needed a new filter set-up due to last set going down from air in lines. Patient was placed on the continuous renal replacement therapy (crrt) machine. About ten minutes after crrt machine was started, patient's bp decreased without response to norepinephrine. Patient's hr decreased and oxygen saturation dropped as well, and pt coded. Cpr was performed, two ampules of epinephrine were given. Patient's heart activity, bp and oxygen saturation returned. Patient's neuro status returned back to previous state before code. Patient was sedated and is currently still sedated. Patient's ionized calcium came back as 1. 12.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1525999 |
| MDR Report Key | 1525999 |
| Date Received | 2009-11-08 |
| Date of Report | 2009-11-08 |
| Date of Event | 2009-10-05 |
| Report Date | 2009-11-08 |
| Date Reported to FDA | 2009-11-08 |
| Date Added to Maude | 2009-11-13 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRISMAFLEX |
| Generic Name | HEMODIALYSIS, CONTINUOUS RENAL REPLACEMENT THERAPY |
| Product Code | MQS |
| Date Received | 2009-11-08 |
| Model Number | PRISMAFLEX |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 6 MO |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GAMBRO RENAL PRODUCTS, INC. |
| Manufacturer Address | VICE PRESIDENT REGULATORY AFFA 14143 DENVER WEST PARKWAY, SUI LAKEWOOD CO 80215 US 80215 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-11-08 |