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

Model Number VMP306

Device Problems Crack (1135); Fluid/Blood Leak (1250); Leak/Splash (1354); Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/08/2018

Event Type  malfunction  

Manufacturer Narrative

One vamp jr.System and a 10ml syringe was returned for examination.The reported event of "leaking" 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 was observed from the pressure tubing and reservoir stopcock.Lot number was not provided, therefore review of the manufacturing records could not be completed.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions.Invasive procedures involve some patient risks.Although serious complications are relatively uncommon, the physician is advised to consider the potential benefits in relation to the possible complications.It is common clinical practice to inspect all products before use.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.Tubing breakage will most likely occur during handling and manipulation of the product and will result in an obvious leak prior to connecting to the patient or during tightening of connections during use.Therefore, the break in the system will be immediately detected.Since these devices are indicated for pediatric patients, whose blood volume is much smaller than an adult, they cannot tolerate blood loss as easily as adults.Consequently, there is potential for patient injury.In this case, there were no patient complications noted.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.

Event Description

It was reported that while using a vamp jr, blood was backing up into the arterial line.The connections were checked and the staff increased the rate the fluid that was infusing, with no success.(what fluid they increased is unknown.) it was then noticed that there was a crack on the vamp connection piece near the port and the medication papaverine was leaking from the crack.No patient complications were reported.Patient demographics unavailable.To date, additional information requests have been made without success.

Manufacturer Narrative

The investigation of this pressure monitoring kit with vamp jr concluded that a potential root cause of leakage at the bond joint between pressure tubing to reservoir stopcock could be related to an incorrect solvent bonding execution during the assembly process.Personnel acknowledgement was conducted at the manufacturing site to prevent recurrence of this type of complaint.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: PRESSURE MONITORING KIT WITH TRUWAVE DISPOSABLE PRESSURE TRANSDUCER AND VAMP JR.
• 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: 8040130
• MDR Text Key: 127372053
• Report Number: 2015691-2018-04539
• 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,Followup
• Report Date: 10/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VMP306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1