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

Model Number 896507001

Device Problems Incorrect Measurement (1383); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914)

Event Date 01/25/2020

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 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 on a traumatic head injury patient, the intracranial pressure (icp) elevated to 25, while using this truwave cable.The arterial transducer line values were faulty.The patient¿s blood pressure began reading 230/130 with a decent trace and no intervention.When more sedation was given, the blood pressure came down to 170/130.Noradrenaline was reduced from 14 to 4.Trace did not indicate a false reading.The non-invasive blood pressure read 80/50 and the heart rate was up to 120.The transducer cable was changed to a different one which gave the correct blood pressure reading concurrent with the non-invasive blood pressure.The patient was stabilized by increasing noradrenaline to give therapeutic blood pressure which resolved the elevated icp.The doctor was present during the whole process.The patient stabilized quickly within 3 minutes after changing the cable.Later, the clinical engineer checked the cable with a transducer and there was no pressure shown on the monitor despite pressure being applied to the transducer.There was no patient injury reported.The device was available for evaluation.There were no error messages displayed, only the alarm for hypertension that was set in the alarm limits.

Manufacturer Narrative

This was reported in error as edwards does not have reporting responsibility.This is a third party product therefore edwards doesn't have risk assessment responsibilities on it.

Manufacturer Narrative

The product was expected to be returned, however, it was then later confirmed that the device was no longer available.The patient demographics were received.Without the return of the product, it is not possible to determine if damages or defects existed on the product, nor can a root cause or any potential contributing factors be identified.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

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: 9881651
• MDR Text Key: 195934502
• Report Number: 2015691-2020-11143
• 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: foreign,health professional,o
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/03/2019
• Device Model Number: 896507001
• Device Lot Number: 155009867
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 19 YR