MAUDE Adverse Event Report: EDWARDS LIFESCIENCES TRIFURCATED TRUWAVE CABLE; CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)

Model Number 896083L3B

Device Problem Incorrect Measurement (1383)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 10/03/2018

Event Type  malfunction  

Manufacturer Narrative

The suspect cable is sold in the eu only; therefore, no existing 510k information is applicable.This report is being communicated because a similar cable is sold and marketed in the u.S.Under model #896083021.The u.S.Cable is not sold in the eu.The cable is expected to be returned for analysis; however, at the time of this report it has not yet been received.Upon return and evaluation, a supplemental report will be sent to communicate the results of our investigation as well as our review of the device history record.

Event Description

It was reported that the blue wire of a trifurcated truwave cable produced measurements which were deemed ¿wrong.¿ the suspect ¿wrong¿ values were not specified.There was no allegation of patient involvement or compromise.Although requested, no further details will be forthcoming, as an additional request to the customer revealed that the device was left on a desk located in the technical department with no other information.

Manufacturer Narrative

Cable (b)(4), lot number 151208234 was manufactured in may 2015.Per edwards lifetime of the product specification, the expected lifetime for the referenced cable is three years.Therefore, at the time of the customer¿s complaint, the cable had exceeded its expected lifetime; the service life of the cable is also influenced by conditions of use.A device history review performed by the manufacturer supports that there were no test failures for the referenced lot number prior to their release to stock.In addition, the manufacturer has not received any other returns for this lot number.The cable was tested on the manufacturer¿s test bench in accordance with production parameters.During testing, a high continuity of 3, 5 ohms was detected on l2 (blue); normal continuity is less than 2 ohms.The continuity on l1 and l3 was correct.The evaluation results were unable to be definitively correlated to the customer¿s allegation of ¿wrong¿ values.An engineering evaluation has been initiated to further investigate any manufacturing non-conformance.With any hemodynamic monitoring, pressure readings can change quickly and dramatically.Pressure readings should correlate with the patient¿s clinical manifestations.No patient injury was reported as a result of the incorrect values.These devices are used by highly trained clinicians experienced in assessing and mitigating any hazards that arise.These devices are typically used in intensive care units or operating rooms where patients are closely monitored.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.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: TRIFURCATED TRUWAVE CABLE
• Type of Device: CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 8010879
• MDR Text Key: 126535905
• Report Number: 2015691-2018-04411
• Device Sequence Number: 1
• Product Code: DSA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2018
• Device Model Number: 896083L3B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2018
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1