MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR PRESSURE MONITORING SET; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number T001657A

Device Problem Inaccurate Flow Rate (1249)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

No product was returned for evaluation; it was discarded at the hospital.Without the return of the product, it is not possible to determine if damages or defects existed on the product, nor could a root cause or potential contributing factors be identified.The lot number for this device was not supplied; therefore, further review of the related manufacturing records could not be performed.The user reported that an unknown amount of saline was considered lost (unaccounted for) from the iv fluid bag attached to this pressure monitoring set.This event is being reported as a conservative measure only based on the possibility that there was an incorrect flow rate caused by the pressure monitoring set resulting in the missing fluid being delivered to the patient.Through the investigation there was no evidence to support that the missing fluid was delivered to the patient.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 in pediatric patient with this pressure monitoring set, unknown amount of saline was lost from the 500 ml saline bag.It was unable to establish if the saline was infused accidentally or drawn out of the bag in theatre by a clinician.There was no allegation of patient injury.Patient demographics unable to be obtained.The device was not available for evaluation.

• Brand Name: PRESSURE MONITORING SET
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal ; DR
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal ; DR
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 15884858
• MDR Text Key: 306451672
• Report Number: 2015691-2022-09552
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K183413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/30/2022

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: T001657A
• Device Catalogue Number: T001657A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/04/2022
• Initial Date FDA Received: 11/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1