MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-12 for EV1000 FLOTRAC CABLE EVFTCL manufactured by Edwards Lifesciences.
[188743836]
The product is expected to be returned for analysis; however, it has not yet been received. Upon the return of the product a supplemental report will be sent with the investigation results. The device history record was reviewed; no related non-conformances were found. No escalation is required. 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 part of this monthly review.
Patient Sequence No: 1, Text Type: N, H10
[188743837]
As reported, during a liver transplant intervention of a patient with this flotrac cable, the central venous pressure (cvp) reading continued to increase to inappropriate values (cvp went up to 40-47 mmhg). At first, there were no issues with cvp monitored via the flotrac cable for about three hours, but then it started to? Drift? Upwards by more than 10 mmhg. The cvp was then re-zeroed but continued to? Drift? Upwards. While still using the flotrac cable, the transducer was changed out to a new one, zeroed, and the upwards drift was still there. The cvp monitoring on the ev1000 was discontinued and the new cvp transducer worked fine when the pressure cable was connected to the patient monitor. It was able to retain its zero and the values did not drift. The case continued with the cvp monitored via the bedside monitor, so the systemic vascular resistance (svr) was not calculated by the ev1000. There was no error message displayed reported. There was no allegation of patient injury. The cable was available for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2020-10941 |
| MDR Report Key | 9826450 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-12 |
| Date of Report | 2020-02-20 |
| Date of Event | 2020-02-08 |
| Date Mfgr Received | 2020-02-20 |
| Device Manufacturer Date | 2019-04-01 |
| Date Added to Maude | 2020-03-12 |
| 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 | 3 |
| Brand Name | EV1000 FLOTRAC CABLE |
| Generic Name | COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION |
| Product Code | DXG |
| Date Received | 2020-03-12 |
| Model Number | EVFTCL |
| Catalog Number | EVFTCL |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-12 |