MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, DR PRESSURE MONITORING KIT WITH TRUWAVE DISPOSABLE PRESSURE TRANSDUCER AND VAMP JR.

Model Number	VMP306PX
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a vmp306px truwave 30cc vamp jr from lot 64615627, had snapped in the middle of the device.It had not been used on a patient.
Additional Manufacturer Narrative
The product is expected to be returned for analysis but has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.Without the return of the product, it is not possible to determine if damages or defects exist on the product, nor can any manufacturing nonconformance, failure mode, root cause, or potential contributing factors be identified.No actions will be taken at this time.A device history record review has been initiated to document if the device met all specifications upon distribution.Complaint histories for all reported events are reviewed against trending control limits, and any excursions above the control limits are assessed and documented as part of this monthly review.
Additional Manufacturer Narrative
Our product evaluation lab received one single dpt vamp jr kit with tyvek lid which showed the reported model and lot number.The customer report of vamp jr.Had snapped in the middle of the device was confirmed.The pressure tubing was found completely broken from the bond joint with the distal vamp reservoir stopcock.Cross surfaces of the broken tubing appeared rough and uneven.Lab findings appeared consistent with the customer photo.No other visible damage was observed from returned kit.Per product evaluation findings, the tube was broken and not detached, therefore this is no longer a reportable event.Complaint histories for all reported events are reviewed against trending control limits, and any excursions above the control limits are assessed and documented as part of this monthly review.

• Brand Name: PRESSURE MONITORING KIT WITH TRUWAVE DISPOSABLE PRESSURE TRANSDUCER AND VAMP JR.
• Common Device Name: PRESSURE MONITORING KIT
• Manufacturer (Section D): EDWARDS LIFESCIENCES, DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer (Section G): EDWARDS LIFESCIENCES; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614 ; 9492507258
• MDR Report Key: 17075988
• Report Number: 2015691-2023-13474
• Device Sequence Number: 6841799
• Product Code: DXO
• UDI-Device Identifier: 07460691950375
• UDI-Public: (01)07460691950375(17)240531(11)221221(10)64615627
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: VMP306PX
• Device Catalogue Number: VMP306PX
• Device Lot Number: 64615627
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2023
• Supplement Date Received by Manufacturer: 06/15/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 06/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/21/2022
• 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
• Patient Sex: Unknown