MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-12-14 for 2008 SORBENT SYSTEM manufactured by Renal Solutions.
[1828097]
A pt was being dialyzed on the 2008 sorbent system and complained of itching of their hands and feet three minutes in the treatment. The pt complained that their tongue and lips were burning. The 2008 sorbent system was placed in "pause" mode. The physician was present and instructed the pt care tech to rinse back the pt's blood and thus cease the dialysis treatment. The pt continued to complain of burning in their throat, then nausea. It was noted that the pt's eyes, lips, and face had some swelling. The pt's blood pressure at the time was 57/33, an ekg reported sinus tachycardia of 147 bpm. Blood pressure had been 126/92, and heart rate 85/min just before start of dialysis. A 50mg of diphenhydramine was given ivp and the pt was placed on o2 at 2l/min. The pt was alert and oriented throughout the incident. The pt was placed on a single pass system and dialyzed as per their usual dialysis treatment. The pt was observed during dialysis by the physician. At the end of the dialysis treatment, vital signs had returned to normal and aside from slight edema of the pt's eyes and the pt's symptoms had subsided. The pt was discharged home. After the pt was taken off of the device, it was concluded that the pt had idiosyncratic reaction to the dialysis procedure as evidence by itchiness, facial swelling and tachycardia. The pt also showed signs of hypertension which ensued after iv benadryl was provided. No permanent sequelae of the incident was observed. The analysis of the laboratory data obtained during this sequence of events indicated hemoconcentration, as evidence by a rise of hematocrit from 30% pre-treatment to with the sorb 2008 machine; it rose to 36% after 7 minutes into treatment and subsequently rose to 42%. The last observed hematocrit was at the end of treatment was 40% and levels of histamine, ige, c3, and c4 were normal.
Patient Sequence No: 1, Text Type: D, B5
[8822097]
The 2008 sorbent system was evaluated by the user facility bio-technician as they were trained to service and verify operation of the system. The 2008 sorbent system (b)(4) was evaluated and found to be operating within the expected as indicated below: operation of the device was verified one day after the incident by the user facility bio-technician; the device was setup and a mock pt treatment was run on it. The unit had no recorded issues and all of the functional parameters indicated that the 2008 sorbent system operated during the mock pt treatment as designed. The console logs from the mock pt treatment were pulled from the device and evaluated by the renal solutions.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005778453-2010-00001 |
| MDR Report Key | 1929832 |
| Report Source | 05 |
| Date Received | 2010-12-14 |
| Date of Report | 2010-12-09 |
| Date of Event | 2010-11-10 |
| Date Mfgr Received | 2010-11-10 |
| Device Manufacturer Date | 2010-05-01 |
| Date Added to Maude | 2011-01-25 |
| 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 2008 SORBENT SYSTEM |
| Generic Name | DIALYSATE DELIVERY, SORBENT REGENERATIVE |
| Product Code | FKT |
| Date Received | 2010-12-14 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RENAL SOLUTIONS |
| Manufacturer Address | WARRENDALE PA 15086 US 15086 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-12-14 |