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

Model Number	PX36N
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Air/Gas in Device (4062)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	01/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device evaluation is anticipated.However, the complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation and device history results when received.Three mdrs mw5114684, mw5114686, & mw5114812 were submitted by customer.Customer confirmed all reports are for one event and acknowledged error.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 or Problem Description
It was reported a loose connector on a transducer caused air to enter an ecmo circuit while in use of a patient.Event occurred in the operating room.Patient required intervention.Additional information is unknown.
Additional Manufacturer Narrative
The reported event of loose connector on a transducer was not able to be confirmed during evaluation.As received all connections were tight and secured.No leakage was detected from the kit during leak test.No visible damage was observed from the kit.All male and female luers of edwards dpt housing, zero stopcock and tubing connectors dimensionally passed iso standards.Edwards ifu instructs to ensure that all connection are secure.Further evaluation regarding related quality issues is under investigation.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.
Additional Manufacturer Narrative
Updates to the h6 codes are as follows investigation findings was changed to no device problem found and investigation conclusions was changed to no problem detected.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: PRESSURE MONITORING KIT WITH TRUWAVE DISPOSABLE PRESSURE TRANSDUCER
• Common Device Name: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 16513125
• Report Number: 2015691-2023-11350
• Device Sequence Number: 20412211
• Product Code: DXO
• UDI-Device Identifier: 07460691950696
• UDI-Public: (01)07460691950696(17)240818(11)220819(10)64453340
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K925638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 08/18/2024
• Device Model Number: PX36N
• Device Catalogue Number: PX36N
• Device Lot Number: 64453340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2023
• Supplement Date Received by Manufacturer: 03/14/2023; 05/08/2023
• Initial Report FDA Received Date: 03/09/2023
• Supplement Report FDA Received Date: 03/30/2023; 05/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown