MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR DISPOSABLE PRESSURE TRANSDUCER KIT; PRESSURE MONITORING KIT WITH TRUWAVE DISPOSABLE PRESSURE TRANSDUCER

Model Number PX260

Device Problem Leak/Splash (1354)

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

Event Date 05/16/2021

Event Type  malfunction  

Manufacturer Narrative

Received one single dpt kit.The reported event of leakage from snap-tab was confirmed.Leakage was observed from dpt snap tab area during leak test.Leakage occurred from a hole, approximately 0.10 in length, on the poppet.A crack of approximately 10mm in size was also observed at the drip chamber body, leakage occurred from the crack.No other visible damage was found from the returned unit.Although serious complications are relatively uncommon, the physician is advised to consider the potential benefits in relation to the possible complications.It is common clinical practice to inspect all products before use.These products are used by highly trained clinicians, experienced in identifying and mitigating any hazards that arise during use.In addition, these devices are typically used in intensive care units or operating rooms, where patients are closely monitored.Medication not being delivered consistently could cause a deterioration in the patients condition and may necessitate additional interventions.It is unknown whether user or procedural factors contributed to the stated event.In this case, there were no patient complications noted.There was no evidence to confirm that the product failure is related to a manufacturing or design defect.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 a part of the monthly review.

Event Description

It was reported that, during use in the recovery room after an aortic valve replacement and coronary artery bypass, this disposable pressure transducer connected to a pump to administer drugs, leaked analgesic medication through the snap tab.The quantity of medication loss is unknown.The issue was solved replacing the device for another one.There was no allegation of patient injury.Patient demographics are not available.

Manufacturer Narrative

A device history record review was completed and documented that device met all specifications upon distribution.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 a part of the monthly review.

• Brand Name: DISPOSABLE PRESSURE TRANSDUCER KIT
• Type of Device: PRESSURE MONITORING KIT WITH TRUWAVE DISPOSABLE PRESSURE TRANSDUCER
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• MDR Report Key: 12010064
• MDR Text Key: 256705277
• Report Number: 2015691-2021-03615
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• PMA/PMN Number: K925638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/08/2022
• Device Model Number: PX260
• Device Catalogue Number: PX260
• Device Lot Number: 63358761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1