MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR PRESSURE MONITORING KIT; PRESSURE MONITORING SET

Model Number TC2785SB01

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/02/2021

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is anticipated.However, the complaint cannot not be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation results when received.

Event Description

It was reported that blood leakage was observed while using this disposable pressure transducer.It was unable to identify from where the leakage occurred.It is pediatric patient, but patient demographics are not available.No additional treatments such as blood transfusion due to the blood loss were necessary.The device was exchanged and the problem was solved.No patient complications were reported by the customer.

Manufacturer Narrative

One single flothru dpt kit with pressure tubing and merit flush device with yellow actuator was recieved for evaluation.The reported event of leakage issue was not confirmed during evaluation.No leakage was observed from the returned kit during leak test.However, a crack was observed at housing of one sample site during visual examination.Crack was approximately 5 mm in length.Other evaluation was opened to document further investigation at supplier facility of the sample site.This non-conformance involves a pediatric dpt that had a blood leakage.If this non-conformance were to occur during use, it has the potential to result in minor blood/fluid loss.This device is used for monitoring pediatric arterial blood pressure and blood sampling.Since these devices are indicated for pediatric patients whose blood volume is much smaller than an adult, they cannot tolerate blood loss as easily as adults.A leak in the system may cause a dampened waveform to be displayed on the patient monitor, thereby alerting the clinician to start the troubleshooting process.This non-conformance may cause a delay in the procedure while the product is exchanged.Lot number was not provided, therefore review of the manufacturing records could not be completed.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: PRESSURE MONITORING KIT
• Type of Device: PRESSURE MONITORING SET
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• MDR Report Key: 11379050
• MDR Text Key: 234028362
• Report Number: 2015691-2021-01444
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: TC2785SB01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1