MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2011-12-30 for 2008 SORBENT SYSTEM manufactured by Renal Solutions, Inc..
[2452680]
A (b)(6) rep notified (b)(4), that a pt became symptomatic while on the 2008 sorbent system. After about 2 minutes at blood flow rate (bfr) of 200 ml/min, the pt care technician increased the bfr to 400 ml/min as prescribed. Within one minute, the pt became symptomatic as follows: itching, (b)(6), swelling of lips, shortness of breath and slightly diaphoretic. The pt was taken off the device after approx 3 minutes of treatment. The pt then was administered 50 mg of benadryl then was evaluated by a physician and noted to be stable. Approx 70 minutes later, the pt became nauseated and began to vomit. The pt was hospitalized for diarrhea based on the pt's age and fragile state, and subsequently was released the following day.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005778453-2011-00001 |
| MDR Report Key | 2401131 |
| Report Source | 05,06,07 |
| Date Received | 2011-12-30 |
| Date of Report | 2011-12-30 |
| Date of Event | 2011-11-30 |
| Date Mfgr Received | 2011-11-30 |
| Device Manufacturer Date | 2010-04-01 |
| Date Added to Maude | 2012-01-09 |
| 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 | DAVID VANELLA |
| Manufacturer Street | 770 COMMONWEALTH DRIVE SUITE 101 |
| Manufacturer City | WARRENDALE PA 15086 |
| Manufacturer Country | US |
| Manufacturer Postal | 15086 |
| Manufacturer Phone | 7247202840 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 2008 SORBENT SYSTEM |
| Generic Name | DIALYSATE DELIVERY. SORBENT REGENERATIVE |
| Product Code | FKT |
| Date Received | 2011-12-30 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RENAL SOLUTIONS, INC. |
| Manufacturer Address | WARRENDALE PA 15086 US 15086 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2011-12-30 |