MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR DISPOSABLE PRESSURE TRANSDUCER KIT

Model Number PXMK20222

Device Problem Air/Gas in Device (4062)

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

Event Date 06/03/2021

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, however, the lot number was not provided thus a device history record was not reviewed.

Event Description

It was reported that the line was filled with air during use.The saline bag was continuously used from (b)(6) 2021 and pap value was normal at 20mmhg/10mmhg in the evening on (b)(6).It was in the morning on (b)(6) when the customer noticed the incident, the pap value was 14mmhg/14mmhg.Then the customer checked the line and realized that the saline bag, the line and the drip chamber were filled with air.Solution leakage was not confirmed as there were no trace of leakage on the patient nor on the floor.Blood backflow was not observed, either.It was confirmed that the air was completely released from both saline bag and drip chamber.There were no patient complications reported.Patient demographics requested but not available.

Manufacturer Narrative

One single double dpt kit with iv set and pressure tubing was returned for evaluation.No priming solution was visible throughout the kit.Iv spike was inserted to empty saline bag.Iv set was clamped by roller clamp and snap clamps.The reported event of leakage issue was not able to be confirmed.As received, all connections appeared tight.No visible defect/damage was observed from the kit during visual examination.Saline bag was disconnected from spike for further evaluation.No leakage was observed from the kit during leak test.The dpt zeroed and sensed pressure accurately on pressure monitor.Electrical testing showed that both input impedance and output impedance were within specifications.Zero-offset also met specification.No visible defect was found from dpt cable connectors.However, additional testing on the flow restrictor will be conducted and a supplemental report will be forthcoming with the evaluation results when received.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.

Manufacturer Narrative

Additional testing was conducted on the flow restrictor and it was concluded that the red and blue dpt flow rates, 2.8 ml/hour and 2.7 ml/hour respectively, were within specification.The reported event of air in the tube and drip chamber could not be confirmed through the product evaluation.

• Brand Name: DISPOSABLE PRESSURE TRANSDUCER KIT
• Type of Device: DISPOSABLE PRESSURE TRANSDUCER KIT
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• MDR Report Key: 12085047
• MDR Text Key: 258947355
• Report Number: 2015691-2021-03813
• 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,Followup
• Report Date: 08/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: PXMK20222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1