MAUDE Adverse Event Report: EDWARDS LIFESCIENCES FLOTRAC CONNECTING CABLE

Model Number EVFTCL

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/04/2014

Event Type  malfunction  

Event Description

It was reported that the mean arterial pressure (map) was inaccurately displayed on the ev1000 monitor.When map displayed as 80mmhg on the patient monitor, it displayed as 40mmhg on the ev1000 monitor.The customer surmised that the value on ev1000 was demonstrably wrong, therefore they exchanged the ev1000 system for a vigileo monitor immediately, and the issue was resolved.Two complaints were initiated; one (1) for the ev1000 monitor and one (1) for the system related component: the flotrac cable.There was no report of patient compromise or inappropriate treatment resulting from the reported event.

Manufacturer Narrative

A device evaluation is anticipated but was not complete at the time of this report.The evaluation results, investigation, and a conclusion will be communicated in a follow-up submission.An additional mdr was submitted for the system-related ev1000 monitor (reference mdr number 2015691-2014-00764).

Manufacturer Narrative

The customer¿s complaint was unable to be replicated during examination of the returned device, as the cable performed as expected with no failures noted for any reason.Conductivity testing was performed with passing results and no physical damage was observed during the visual inspection.Therefore, the flotrac connecting cable can reasonably be exempted as a contributor to the customer¿s complaint.A system-related ev1000 monitor malfunction was identified as the root cause of the customer¿s experience (reference mdr 2015691-2014-00764).The flotrac cable will be returned to the customer.

• Brand Name: FLOTRAC CONNECTING CABLE
• Type of Device: CABLE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• Manufacturer Contact: lynn selawski ; 1 edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 3723046
• MDR Text Key: 4308229
• Report Number: 2015691-2014-00767
• Device Sequence Number: 1
• Product Code: ISN
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K043065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EVFTCL
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/27/2014
• Initial Date FDA Received: 04/02/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1