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

Model Number VO4201TS01(PL)_

Device Problems Particulates (1451); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/13/2018

Event Type  malfunction  

Manufacturer Narrative

One single dpt-vamp flex kit with an iv set and pressure tubing were returned for examination.The reported event of ¿vamp flex syringe was found to be filled with unknown black liquid or solid material¿ was confirmed.An unknown brown material was observed in the solution inside of the vamp flex unit and dpt.The solution in pressure line was cloudy.No other abnormality was observed throughout the kit during a visual examination.The plunger of vamp flex was pushed to a closed position and the vamp flex was shut-off using the reservoir stopcock, flushing continuously for 5 minutes.Brown material pieces were captured in the zero-stopcock or remained in the elbow.However, small pieces of the brown material which had been in the solution were flushed out from the kit.The chemistry study results detected the following elements: sulfur, silicon, and fluoride.The ir spectrum of the unknown brown material from the inner wall of the elbow connector showed similar absorption characteristics when comparing to silicone like material.The ir spectrum of the elbow connector (outside surface, free from the brown material) showed similar absorption characteristics when comparing to pvc like material.Lot number was not provided, therefore review of the manufacturing records could not be completed.An investigation is underway to ascertain if any of the elements found are used in any part of the manufacturing process it is common clinical practice to inspect all products before and periodically during use.Additionally, these products are used by highly trained clinicians, experienced in identifying and mitigating any hazards that arise.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.Particulates that are in the fluid path could enter the bloodstream, potentially embolizing and resulting in patient injury or infection.In this case there was no patient injury or complications.It is unknown if user or procedural factors contributed to the stated 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.The 510k number is unknown as this is a customer defined product.

Event Description

It was reported that the vamp flex syringe was found to be filled with an unknown black liquid or solid material on the second day of use.Patient demographic information requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

An investigation of the reported issue concluded the contents found in the substance inside of the vamp flex are not a part of the manufacturing process.Silicon is not used in the (b)(6) or the (b)(6) manufacturing plants.Therefore, this issue is not deemed to be attributed to a manufacturing non-conformance.

Manufacturer Narrative

Reference capa-20-0014.

• Brand Name: JAPAN CUSTOMER 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: 7850790
• MDR Text Key: 119816890
• Report Number: 2015691-2018-03692
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• 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: 06/13/2018

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 Model Number: VO4201TS01(PL)_
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2018
• Initial Date Manufacturer Received: 08/15/2018
• Initial Date FDA Received: 09/06/2018
• Supplement Dates Manufacturer Received: 09/27/2018; 07/23/2020
• Supplement Dates FDA Received: 09/28/2018; 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1