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

Model Number VO3906TS02PL_

Device Problems Material Integrity Problem (2978); Appropriate Term/Code Not Available (3191)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 12/06/2018

Event Type  malfunction  

Manufacturer Narrative

One single flothru dpt-vamp flex kit with an iv set and pressure tubing was returned for examination.The reported event of leakage issue was not confirmed.As received into the decontamination lab, priming solution was visible throughout the kit and air was not visible in the line.As received into the evaluation lab, all connections appeared tight.No visible damage or defect was observed from the kit during a visual examination.No leakage was observed from the kit during a leak test.A simulated use test was also performed to the vamp flex in attempt to identify if leakage had occurred from the vamp.No leakage was observed during simulated use test per the ifu recommendations.It was recommended by ifu to move the plunger at rate of "1 second for each ml of clearing volume" during aspiration and injection of blood from the reservoir.The sample sites also functioned properly with a returned 10ml syringe, and no leakage was observed while sampling from the sample sites.Lot number was not provided, therefore review of the manufacturing records could not be completed.The reported event could not be confirmed or replicated during the analysis, as the device responded appropriately during functional testing.There was no evidence of a manufacturing nonconformance.No further actions will be taken at this time.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.In this case, there were no patient complications noted.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

In this event, 30cc of air was pulled into the syringe when the customer drew blood after approximately 30 hours of use.At this time, it is unable to be determined if the air was in the pressure line or the air pulled into the syringe because of an unsecured connection of the syringe to the sample site.The device was used with a femoral artery catheter through an introducer.Before this incident happened there was no problem indicated during blood sampling.There were no patient complications reported.Patient demographics were unable to be obtained.No patient demographics available at this time.

Manufacturer Narrative

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

• Brand Name: 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: 8181908
• MDR Text Key: 131318527
• Report Number: 2015691-2018-05445
• 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
• Report Date: 12/06/2018

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: VO3906TS02PL_
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Initial Date Manufacturer Received: 12/06/2018
• Initial Date FDA Received: 12/19/2018
• Supplement Dates Manufacturer Received: 07/23/2020
• Supplement Dates FDA Received: 11/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1