MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-09 for THERMOSET REF 41424-03 manufactured by Icu Medical.
[116911796]
When injecting from the 10cc syringe to shoot a cardiac output, the red valve just distal to the syringe leaks the injectate each time the cardiac output is injected. This can alter the cardiac output results. This in turn could harm the pt if treatment is given for inaccurate results. Only able to replicate when connected to a pt, which is unsafe.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5079030 |
| MDR Report Key | 7772415 |
| Date Received | 2018-08-09 |
| Date of Report | 2018-08-08 |
| Date of Event | 2018-07-23 |
| Date Added to Maude | 2018-08-10 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | THERMOSET |
| Generic Name | PROBE, THERMODILUTION |
| Product Code | KRB |
| Date Received | 2018-08-09 |
| Model Number | REF 41424-03 |
| Lot Number | MULTIPLE LOTS: 3656680 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ICU MEDICAL |
| Manufacturer Address | SAN CLEMENTE CA 92673 US 92673 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-08-09 |