MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR VAMP JR PRESSURE MONITORING KIT; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number PXVJ356

Device Problem Leak/Splash (1354)

Patient Problem Not Applicable (3189)

Event Date 01/18/2018

Event Type  malfunction  

Manufacturer Narrative

One sealed vamp jr.System was returned for examination.The reported event of "leak at the syringe and soft tubing connection point next to the stopcock" was confirmed.Leakage was detected at the bond joint between the pressure tubing to reservoir stopcock.Red dye solution was manually injected into the vamp system to trace the leak path.Leakage was found occurring across the bond area.No visible damage or defect was observed from pressure tubing and reservoir stopcock.The tubing outer diameter was measured near the point of detachment and found to be within specification.Invasive procedures involve some patient risks.Although serious complications are relatively uncommon, the physician is advised, before deciding to use the system, to consider the potential benefits in relation to the possible complications.In this case, leakage could occur in a pediatric patient, who would have a lower threshold for minor amounts of bleeding than an adult patient.This results in a higher potential for an injury to occur.These products are used by highly trained clinicians, experienced in identifying and mitigating any hazards that arise during use.In addition, these devices are typically used in intensive care units or operating rooms, where patients are closely monitored.In this vamp jr.System, there is a stopcock that allows the clinician to quickly shut off the line before the point of the leak.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions.A review of the manufacturing records indicated that the product met specifications upon release.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.(b)(4).

Event Description

It was reported there was a leak at the syringe and soft tubing connection point next to the stopcock of this vamp jr.Kit.No patient involvement as a sealed representative sample was returned.

Manufacturer Narrative

Per root cause analysis performed, it can be concluded that the reported event of leakage issue could potentially be associated with not having the proper execution of the solvent bonding process.It is possible that the operator did not follow the proper instructions in executing the amount of solvent needed.Personnel acknowledgment was performed regarding this issue.

• Brand Name: VAMP JR PRESSURE MONITORING KIT
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal ; DR
• MDR Report Key: 7306525
• MDR Text Key: 101506482
• Report Number: 2015691-2018-00681
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• PMA/PMN Number: K925638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/19/2018

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 Expiration Date: 07/13/2018
• Device Model Number: PXVJ356
• Device Catalogue Number: PXVJ356
• Device Lot Number: 60760761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2018
• Initial Date Manufacturer Received: 02/09/2018
• Initial Date FDA Received: 03/01/2018
• Supplement Dates Manufacturer Received: 05/02/2018
• Supplement Dates FDA Received: 05/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1