MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, DR PRESSURE MONITORING KIT

Model Number PXMKP11359

Device Problem Contamination (1120)

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

Event Date 01/30/2024

Event Type  malfunction  

Event Description

It was reported that there was contamination identified inside the iv tubing of the pressure monitoring kit.This was prior to use.There was a white particulate like material found inside the iv tubing above the roller clamp.There was no patient involvement.

Manufacturer Narrative

The device has been received and will be evaluated and the results are pending.Once the results are available, a supplemental submission will be sent.The device history record review is pending.The results will be sent when the results are available.

Manufacturer Narrative

The device was received for product evaluation.The evaluation findings confirmed the reported issue.One white particulate was observed in the flow path of the iv tubing at approximately 24cm from the spike.The particulate was approximately 1 mm x 0.5 mm in size.The whole line was flushed continuously for five minutes and the particulate moved to approximately 94 cm from the spike.However, it stayed inside the iv set.There was no other inconsistency observed.Further in depth analysis through the third party supplier found the white particulate material to be consistent with that of latex.After a thorough review, the third party supplier manufacturing processes and associated items are well controlled and devoid of latex.The tubing and components in question are supplied by edwards.As there was a presence of visible solution in the iv set, it is probable that the latex contamination originated from other operations beyond the third partys control.Regardless, the relevant operators will be trained to enhance their awareness and caution regarding this issue.The device history record review was completed and all manufacturing inspections passed with no non conformances.An engineering evaluation has been initiated to assess for any manufacturing related processes within edwards which could be correlated to the complaint.

• Brand Name: PRESSURE MONITORING KIT
• Type of Device: PRESSURE MONITORING KIT
• Manufacturer (Section D): EDWARDS LIFESCIENCES, DR; parque industrial de itabo; carr sanchez km 18.5; haina, san cristobal ; DR
• Manufacturer (Section G): EDWARDS LIFESCIENCES, DR; parque industrial de itabo; carr sanchez km 18.5; haina, san cristobal ; DR
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614 ; 9492507258
• MDR Report Key: 18744233
• MDR Text Key: 336089914
• Report Number: 2015691-2024-01179
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K925638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PXMKP11359
• Device Lot Number: YK1080MT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: No
• 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