MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-10-30 for CENTRYSYSTEM 3 PLUS manufactured by Gambro.
[1248492]
Customer reported they had five pyrogen reactions associated with three centrysystem 3 plus machines over a four week period. Forty minutes into a hemodialysis treatment, the pt complained of chilling and groin pain. Blood cultures were obtained. The pt completed the treatment and was then transferred to the emergency room and admitted to the hospital with a diagnosis of septicemia. The pt was discharged home after two days.
Patient Sequence No: 1, Text Type: D, B5
[8358802]
Visual inspection of the balance chamber diaphragm revealed there were no visible external defects. The diaphragms were disseminated and visual inspection revealed suspect bio-burden build up on the balance chamber diaphragms. There were small visible tears or perforations in both balance chamber diaphragms along with significant material deformation or puckering. The root cause analysis for the reported condition is related to inadequate or not properly or routinely cleaning and disinfecting the machine according to the cobe centrysystem 3 plus operator's manual. The chemical dwell time was decreased from 120 minutes to 15 minutes which is inadequate to control microorganism levels to be within the guidelines. Gambro has found no evidence to suggest that any gambro device caused or contributed to this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1713683-2009-00005 |
| MDR Report Key | 1519391 |
| Report Source | 05,06 |
| Date Received | 2009-10-30 |
| Date of Report | 2008-09-04 |
| Date of Event | 2008-08-19 |
| Date Mfgr Received | 2008-09-04 |
| Device Manufacturer Date | 1999-01-27 |
| Date Added to Maude | 2009-11-04 |
| 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 PARKWAY |
| Manufacturer City | LAKEWOOD CO 80401 |
| Manufacturer Country | US |
| Manufacturer Postal | 80401 |
| Manufacturer Phone | 3032314043 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CENTRYSYSTEM 3 PLUS |
| Generic Name | HEMODIALYSIS MACHINE |
| Product Code | FII |
| Date Received | 2009-10-30 |
| Model Number | CENTRYSYSTEM 3 PLUS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GAMBRO |
| Manufacturer Address | 14143 DENVER WEST PARKWAY LAKEWOOD CO 80401 US 80401 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2009-10-30 |