MAUDE Adverse Event Report: EDWARDS LIFESCIENCES TRUWAVE; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number 896507001

Device Problems Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/23/2020

Event Type  malfunction  

Manufacturer Narrative

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 previous related record of servicing.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.

Event Description

As reported, after zeroing both the ev1000ni system and the patient monitor using this truwave cable, there were inaccurate values displayed on the patient monitor.The incorrect values were for blood pressure.There were no inaccurate values displayed on the ev1000 monitor.The expected values according to the patient's status were similar to the one provided by clearsight technology.There was no error messages displayed.The patient was not treated according to the inaccurate values.The customer was aware of this issue and only relied on the ev1000 platform.Many zeroing attempts were made after that; however, the values were still different.There was no allegation of patient injury.The device was available for evaluation.

Manufacturer Narrative

The truwave cable was returned for evaluation.It was evaluated and tested according to production requirements.There was no fault found.The cable was tested as good.The serial number was received.The device history record review will be performed by the manufacturer, as edwards does not have reporting responsibilities for this device under contractual agreement with a third party vendor.With any hemodynamic monitoring, patient parameters can change quickly and dramatically.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.It is unknown whether any user or procedural factors contributed to this reported event.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

Updating fda reporting follow up task owner.

• Brand Name: TRUWAVE
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 10280485
• MDR Text Key: 199833330
• Report Number: 2015691-2020-12528
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• PMA/PMN Number: K142749
• 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: 06/24/2020

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 Expiration Date: 06/03/2023
• Device Model Number: 896507001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2020
• Initial Date Manufacturer Received: 06/24/2020
• Initial Date FDA Received: 07/15/2020
• Supplement Dates Manufacturer Received: 09/16/2020; 07/23/2020
• Supplement Dates FDA Received: 09/21/2020; 11/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1