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

Model Number 896083L1B

Device Problems Display or Visual Feedback Problem (1184); Incorrect Measurement (1383)

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

Event Date 03/18/2019

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 as well as the device history record.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, during use with a patient, this truwave cable led to a misleading arterial pressure measurement.The values were about 309/200 mmhg and were not in line with the patient's clinical state.There was no error message displayed with these values.It was confirmed that the patient was not treated due to the wrong values.There was no patient details available.There was no allegation of patient injury.The cable was available for evaluation.

Manufacturer Narrative

Per follow up, new information was received that at this hospital, the cables were not routinely tested.It was also learned that there was some confusion about the first faulty cable incident.It appears the cable was put aside but not removed from the theatre.The biomed who reported the incident says that there is a possibility the cable was returned to use and is in fact the same cable involved in a second incident.

Manufacturer Narrative

The product was returned to the manufacturer for evaluation.The cable passed all the tests, with no faults found.It was also realized during the evaluation that edwards does not have reporting responsibilities for this device under contractual agreement with a third party vendor.With any hemodynamic monitoring, pressure readings can change quickly and dramatically.Pressure readings should correlate with the patient¿s clinical manifestations.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 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

Reference capa-20-00141.

• Brand Name: TRUWAVE
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 8557932
• MDR Text Key: 143893969
• Report Number: 2015691-2019-01503
• 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,Followup
• Report Date: 04/05/2019

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: 896083L1B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2019
• Initial Date Manufacturer Received: 04/05/2019
• Initial Date FDA Received: 04/26/2019
• Supplement Dates Manufacturer Received: 04/25/2019; 06/26/2019; 07/23/2020
• Supplement Dates FDA Received: 05/24/2019; 07/08/2019; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1