MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-07 for ICED THERMOSET INJECTATE DELIVERY SYSTEM 41423-03 manufactured by Icu Medical, Inc..
[107717922]
A (b)(6) male patient underwent six vessel coronary artery bypass graft surgery. During procedure, the cardiac output device gave wrong reading. Upon inspection, it was noted that the tubing from the iced thermoset delivery system would not connect properly and leak out. The leak occurred from the male end of the tubing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5077075 |
| MDR Report Key | 7494338 |
| Date Received | 2018-05-07 |
| Date of Report | 2018-05-03 |
| Date of Event | 2018-04-09 |
| Date Added to Maude | 2018-05-08 |
| 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 | ICED THERMOSET INJECTATE DELIVERY SYSTEM |
| Generic Name | PROBE, THERMODILUTION |
| Product Code | KRB |
| Date Received | 2018-05-07 |
| Model Number | 41423-03 |
| Lot Number | 3598129 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ICU MEDICAL, INC. |
| Manufacturer Address | SAN CLEMENTE CA 92673 US 92673 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-07 |