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

Model Number PXVFP11149

Device Problem Contamination (1120)

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

Event Date 05/31/2023

Event Type  malfunction  

Event Description

It was reported that a foreign material was found inside the syringe of a pxvfp11149 pressure monitoring set before use.There were no patient complications reported.

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 was initiated to document whether 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.

Manufacturer Narrative

A supplemental mdr is being submitted due to the product evaluation findings and device history review.Our product evaluation lab received one single dpt-vamp flex kit with iv set and pressure tubing.The pressure tubing remained coiled with paper band.The solution was visible throughout the kit except the vamp flex.One blue particulate was observed near piston inside vamp flex reservoir during visual examination.The particulate was approximately 4 mm x 1 mm in size.The shut-off valve of vamp flex unit was turned to open position, and the whole line was flushed continuously for 5 minutes, but the blue particulate stayed at the same location inside vamp flex after 5 minutes of continuous flushing.No other visible defect or damage was observed on the returned kit.A device history record review was completed and documented that the device met all specifications upon distribution.The customer report of foreign material found inside the syringe was confirmed.The blue particulate was sent to irvine chemistry for further analysis.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.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.

Manufacturer Narrative

A supplemental mdr is being submitted due to the other evaluation findings.Sections h2 has been updated.Per chemistry study the ir spectrum of the blue particulate was consistent with that of synthetic latex.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
• Type of Device: PHOENIX DISPOSABLE PRESSURE TRANSDUCER
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; parque industrial de itabo; 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 ; 9492507258
• MDR Report Key: 17184459
• MDR Text Key: 317805905
• Report Number: 2015691-2023-14148
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K925638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/21/2023

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
• Device Operator: Health Professional
• Device Model Number: PXVFP11149
• Device Lot Number: XU0832MT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/08/2023
• Initial Date FDA Received: 06/22/2023
• Supplement Dates Manufacturer Received: 07/11/2023; 08/03/2023
• Supplement Dates FDA Received: 07/31/2023; 08/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1