MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-20 for CC CABLES 70CC2 manufactured by Edwards Lifesciences.
[117998287]
The cable is expected to be returned to be evaluated. A supplemental report will be submitted to communicate the dhr review results as well as the investigation results. With any hemodynamic monitoring, physiologic parameters can change quickly and dramatically. Physiologic parameters are used to base clinical treatment decisions. In this event, the blood temperature reading was out of range, which would cause an incorrect cco value to be displayed. Clinicians are trained to evaluate the entire clinical presentation of the patient in order to make treatment decisions. In addition, these devices are used by highly trained clinicians experienced in assessing and mitigating any hazards that arise. Complaint histories for all reported events are reviewed against trending control limits on a monthly basis and any excursions above the control limits are assessed and documented as a part of the monthly review
Patient Sequence No: 1, Text Type: N, H10
[117998288]
It was reported that during use of this 70 cc2 cable, the blood temperature (bt) was 38 degrees celsius but then it fluctuated to 17 degrees celsius after about one second. There was no error message observed. No patient injury was reported and no treatment was given to the patient. Patient demographics are unavailable. The suspect cable was replaced and the issue was resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2018-03441 |
| MDR Report Key | 7798056 |
| Date Received | 2018-08-20 |
| Date of Report | 2018-08-06 |
| Date of Event | 2018-08-06 |
| Date Mfgr Received | 2018-08-21 |
| Date Added to Maude | 2018-08-20 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. SAMANTHA EVELEIGH |
| Manufacturer Street | ONE EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9492503939 |
| Manufacturer G1 | EDWARDS LIFESCIENCES LLC |
| Manufacturer Street | ONE EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CC CABLES 70CC2 |
| Generic Name | CABLE |
| Product Code | ISN |
| Date Received | 2018-08-20 |
| Returned To Mfg | 2018-08-21 |
| Model Number | 70CC2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EDWARDS LIFESCIENCES |
| Manufacturer Address | ONE EDWARDS WAY IRVINE CA 92614 US 92614 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-20 |