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.
[118097476]
The cable is expected to be returned and be evaluated. A supplemental report will be submitted to communicate the device history record review results as well as the investigation results.
Patient Sequence No: 1, Text Type: N, H10
[118097477]
It was reported that during use of the 70 cc2 cable, the blood temperature (bt) was unstable from 48? Celsius to 10? Celsius. When the suspect cable was replaced, the issue was improved. No alarm or error message was observed. No patient injury was reported and there was no treatment given to patient due to this event. Patient demographics are unavailable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2018-03456 |
| MDR Report Key | 7799405 |
| Date Received | 2018-08-20 |
| Date of Report | 2018-08-06 |
| Date of Event | 2018-08-06 |
| Date Mfgr Received | 2018-08-29 |
| Device Manufacturer Date | 2009-11-18 |
| 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 | 2018-08-29 |
| Model Number | 70CC2 |
| Device Expiration Date | 2012-11-18 |
| 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 |