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 2012-10-12 for 2008 SORBENT SYSTEM manufactured by Renal Solutions Inc..
[2918871]
A (b)(6) representative notified renal solutions inc (rsi) that a patient became symptomatic while on a 2008 sorbent system. Within 5 minutes into treatment, the patient presented itching in both hands, her face flushed, and was mildly sweaty. The physician lowered the ultrafiltration goal from 1800 ml to 1500 ml after a blood pressure (bp) of 84/47 from a pre treatment bp of 124/62 and starting bp of 116/61. The patient did not seem at any moment to be in major distress, was completely alert, and talkative. After 10 minutes, the itching diminished and by 45 minutes the symptoms had subsided. For precautionary reasons the patient was switched to a different hemodialysis machine (2008k machine) to complete the treatment. At the end of the treatment, the patient felt completely fine with no difference from other dialysis and went home.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005778453-2012-00001 |
| MDR Report Key | 2794752 |
| Report Source | 05,06,07 |
| Date Received | 2012-10-12 |
| Date of Report | 2012-10-04 |
| Date of Event | 2012-09-07 |
| Date Mfgr Received | 2012-09-10 |
| Device Manufacturer Date | 2010-06-01 |
| Date Added to Maude | 2012-10-25 |
| 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 |
| 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 | 2012-10-12 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| 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. Required No Informationntervention | 2012-10-12 |