MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-02-08 for RENALIN 100 UNK manufactured by Minntech Corp..
[786144]
Facility reports possible renalin reaction with one pt. Pt was hospitalized.
Patient Sequence No: 1, Text Type: D, B5
[7953437]
Eval was interviewing nurse mgr in 2008, who reported 3 mins into treatment, the pt complained of shortness of breath, chest pain, was diaphoretic and had a feeling of impending doom. Treatment was stopped and the dialyzer was checked to make sure it was the pt's own dialyzer (it was). Due to the pt feeling so bad, they did not re-initiate dialysis on a "dry pack" but sent the pt directly to the hosp where he was admitted. (pt was hospitalized six days prior, and released three days later). No other info is available at this time as to what type of treatment pt received while in the hosp. Pt was being dialyzed with an asahi rexeed 18r dialyzer that had been reprocessed 12 times. Nurse mgr stated the blood pathway was checked for renalin residuals using renalin residual test strips before the pt was connected to machine. The results were negative. After the pt had the reaction, a biomed tech checked the dialysate side for renalin residuals. The results were positive. Mfr does not recommend checking for residuals at the dialysate ports because a "clean catch" cannot be assured. Hanson connectors can hold residual renalin in them which would give the strip a "false positive" result for the dialyzer. Nurse mgr stated the pt is doing fine with no ill after effects from this incident.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2150060-2008-00002 |
| MDR Report Key | 996578 |
| Report Source | 05,06 |
| Date Received | 2008-02-08 |
| Date of Report | 2008-02-08 |
| Date of Event | 2008-01-08 |
| Date Facility Aware | 2008-01-09 |
| Report Date | 2008-02-08 |
| Date Mfgr Received | 2008-01-09 |
| Device Manufacturer Date | 2007-12-14 |
| Date Added to Maude | 2008-02-14 |
| 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 | 3 |
| Manufacturer Street | 14605 28TH AVE. NORTH |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal | 55447 |
| Manufacturer Phone | 7635533300 |
| Manufacturer G1 | MINNTECH CORP. |
| Manufacturer Street | 14605 28TH AVE. NORTH |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55447 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RENALIN 100 |
| Generic Name | COLD STERILANT |
| Product Code | LIF |
| Date Received | 2008-02-08 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | 201031 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 966287 |
| Manufacturer | MINNTECH CORP. |
| Manufacturer Address | 14605 28TH AVE. NORTH MINNEAPOLIS MN 55447 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2008-02-08 |