MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR VAMP VENOUS ARTERIAL BLOOD MANAGEMENT PROTECTION SYSTEM; KIT, SAMPLING, ARTERIAL BLOOD

Model Number 48VMP106

Device Problem Leak/Splash (1354)

Patient Problems Unspecified Infection (1930); Blood Loss (2597)

Event Date 06/13/2019

Event Type  Injury  

Manufacturer Narrative

One vamp adult was returned for examination.The reported event of leakage in the tap was confirmed.Blood residues were observed between the stopcock core and housing.However, no leakage was observed from the stopcock during a leak test.Furthermore, a simulated use test was performed to the vamp system, but no leakage was detected past the seal during simulated use test if the ifu recommendations were followed.The ifu recommends to smoothly and evenly move the plunger at rate of 5 ml per 3-5 seconds during aspiration and injection of blood from the reservoir.No blood residues were evident between the seal or reservoir.No visible damage was observed from stopcock and the rest of the unit during a visual examination.A review of the manufacturing records indicated that the product met specifications upon release.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.It is unknown if user or procedural factors contributed to the event.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 during use of this pressure monitoring set with a vamp adult, when pulling blood for collection the system leaked at the shut-off valve and the amount of blood loss was approximately 5 ml.The amount of blood lost did not cause injury to the patient.However, the patient had catheter infection; the customer could not confirm if the infection was due to the valve having an opening.The patient took antibiotics for the infection.The product was available for evaluation.

Manufacturer Narrative

The investigation of leakage at the shut-off valve of a vamp adult kit found that the potential root cause for this nonconformance could be a supplier material defect.As this defect cannot be generated at our manufacturing process, the supplier was notified.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: VAMP VENOUS ARTERIAL BLOOD MANAGEMENT PROTECTION SYSTEM
• Type of Device: KIT, SAMPLING, ARTERIAL BLOOD
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal ; DR
• MDR Report Key: 8962836
• MDR Text Key: 156627984
• Report Number: 2015691-2019-03307
• Device Sequence Number: 1
• Product Code: CBT
• Combination Product (y/n): N
• PMA/PMN Number: CLASS I EXEM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/08/2021
• Device Model Number: 48VMP106
• Device Lot Number: 61804823
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 95