MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-12-29 for CENTRYSYSTEM 3 333100001 manufactured by Gambro Renal Products.
[1787515]
Gambro was notified of a critically ill pt that experienced a cardiac arrest approximately ten minutes into a hemodialysis treatment. The pt was successfully resuscitated; however, expired later the same day. Minimal info was available secondary to the time elapsed between the date of the event, and the date gambro was notified. According to the nurse manager there was no reason to believe that any equipment or product caused or contributed to this event. The cartridge blood tubing set was discarded by the facility. The machine was not inspected at the time of the event.
Patient Sequence No: 1, Text Type: D, B5
[8868764]
Device was not inspected at the time of the event, user facility was unable to provide serial number of the machine involved. User facility did not know the exact machine that had been used on the pt at the time of the event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1713683-2010-00001 |
| MDR Report Key | 1947375 |
| Report Source | 05,06 |
| Date Received | 2010-12-29 |
| Date of Report | 2010-12-03 |
| Date of Event | 2010-09-16 |
| Date Mfgr Received | 2010-12-03 |
| Date Added to Maude | 2011-01-10 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ELEANOR BUSTOS |
| Manufacturer Street | 14143 DENVER WEST PKWY #400 |
| Manufacturer City | LAKEWOOD CO 80401 |
| Manufacturer Country | US |
| Manufacturer Postal | 80401 |
| Manufacturer Phone | 3032226664 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CENTRYSYSTEM 3 |
| Generic Name | HEMODIALYSIS MACHINE |
| Product Code | FKP |
| Date Received | 2010-12-29 |
| Model Number | CENTRYSYSTEM 3 |
| Catalog Number | 333100001 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GAMBRO RENAL PRODUCTS |
| Manufacturer Address | 14143 DENVER WEST PKWY #400 LAKEWOOD CO 80401 US 80401 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-12-29 |