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 05/15/2014

Event Type  malfunction  

Event Description

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.

Manufacturer Narrative

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.

Manufacturer Narrative

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.

• 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 DR; parque industrial de itabo; carr.sanchez, km 18.5; haina, san cristobal ; DR
• Manufacturer Contact: lynn selawski ; 1 edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 3870958
• MDR Text Key: 4507138
• Report Number: 2015691-2014-01380
• 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,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2014
• 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
• Date Manufacturer Received: 07/31/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1