MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR PRESSURE MONITORING SET WITH VAMP JR; CATHETER, CONTINUOUS FLUSH

Model Number VMP306PX

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 03/30/2022

Event Type  malfunction  

Event Description

As reported, during use in an infant with this pressure monitoring set with vamp, it was noticed that the original vented cap had not been exchanged to non-vented cap during priming and therefore line solution was leaking.As per customers opinion this might result in risk of infection or air embolism.The infant was continued on antibiotics prophylactically for a few more days than planned.It was clarified that the process step of exchanging the vented cap for non-vented cap at the time of line insertion is explained in the internal training of the hospital.There was no allegation of patient injury.Patient demographics not provided.

Manufacturer Narrative

It was further informed that the device was not available for evaluation since it was discarded at hospital.Without return of the product, edwards is unable to perform a complete investigation of the reported event.The lot number for this device was not supplied; therefore, further review of the related manufacturing records could not be performed.An engineering investigation has been initiated to consider any potential factors that may have contributed to this complaint.The instruction for use indicate "replace all vented caps on the sideports of the stopcocks with non-vented caps".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 part of this monthly review.

• Brand Name: PRESSURE MONITORING SET WITH VAMP JR
• Type of Device: CATHETER, CONTINUOUS FLUSH
• 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
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 14217265
• MDR Text Key: 290151999
• Report Number: 2015691-2022-05427
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K173586
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/27/2022

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: VMP306PX
• Device Catalogue Number: VMP306PX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/04/2022
• Initial Date FDA Received: 04/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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