MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2014-06-13 for FLOTRAC CONNECTING CABLE EVFTCL manufactured by Edwards Lifesciences.
[4507138]
It was reported that although arterial pressure was adjusted to zero, the waveform was not displayed. Additionally, the central venous pressure (cvp) was incorrect. It is unknown whether any error message was displayed and the specific details of the displayed values were not provided and remain unknown. However, the patient monitor displayed what were concluded to be normal values; therefore, the customer surmised that the cvp value was demonstrably wrong, resulting in the ev1000 being exchanged for a vigileo monitor. After the monitor exchange, the issue was successfully resolved. No patient compromise was reported and no additional system-related devices were identified as suspect.
Patient Sequence No: 1, Text Type: D, B5
[11934522]
The cable was manufactured 02-jul-2012. As this cable is an un-serialized product, the device history record was unable to be reviewed. Examination of the cable was unable to confirm the customer? S complaint. Conductivity testing results support that the cable met all functional requirements and no other issues were identified. No physical damage was observed during the visual inspection. It is unknown whether procedural processes or a specific circumstance played a role in the customer? S experience, as no fault could be identified. The cable will be returned to the customer.
Patient Sequence No: 1, Text Type: N, H10
[11974383]
Evaluation of the suspect device is anticipated but was not completed at the time of this report. A follow-up submission will communicate the results of the device history review, returned product evaluation result, investigation, and conclusion.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2015691-2014-01380 |
| MDR Report Key | 3870958 |
| Report Source | 01,05,06 |
| Date Received | 2014-06-13 |
| Date of Report | 2014-05-15 |
| Date of Event | 2014-05-15 |
| Date Mfgr Received | 2014-07-31 |
| Device Manufacturer Date | 2012-07-02 |
| Date Added to Maude | 2014-06-13 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. LYNN SELAWSKI |
| Manufacturer Street | 1 EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9497564386 |
| Manufacturer G1 | EDWARDS LIFESCIENCES DR |
| Manufacturer Street | PARQUE INDUSTRIAL DE ITABO CARR.SANCHEZ, KM 18.5 |
| Manufacturer City | HAINA, SAN CRISTOBAL |
| Manufacturer Country | DR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLOTRAC CONNECTING CABLE |
| Generic Name | CABLE |
| Product Code | ISN |
| Date Received | 2014-06-13 |
| Model Number | EVFTCL |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2014-06-13 |