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

Model Number CK1206Y04

Device Problem Improper Flow or Infusion (2954)

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

Event Date 02/05/2019

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is currently in process.However the complaint cannot not be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation results when received.Lot number was not provided, therefore review of the manufacturing records could not be completed.

Event Description

It was reported that an incorrect flow rate was observed through a flotrac system during use.The customer connected the flotrac with a bag of 500ml saline solution containing novastan hi x3 ampules.The pressure bag was used to maintain the patency rate of 3cc¿s an hour through the line.The saline solution bag was observed to be empty on the first day of use.The pressure bag was replaced as it was thought to be the problem.The second day, 500cc of fluid was infused through the flotrac line therefore the flotrac was found to be suspect.No patient complications were reported.Follow up attempts were made for information on patient co-morbidities and fluid restriction status without success to date.Patient demographics unavailable at this time.

Manufacturer Narrative

One double pressure tubing kit with an attached merit flush device and iv set was returned for examination.The reported event of flow rate issue was not able to be confirmed during the evaluation.A general examination was performed to the returned sample.As received into the laboratory, all connections appeared tight.No visible defect was observed from the kit.The device was able to prime throughout the kit without indication of occlusion or flow restriction.However, the flow speed was visually faster on the red line than on the blue line even when fast flush was not activated with pulling the snap tab or squeezing the actuator.No leakage was observed from the kit during leak test.The flow rate could not be measured during evaluation since edwards evaluation procedure was not applicable for flow rate testing of the merit flush device.The flush device will be sent to merit to conduct a flow rate test of their device.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.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 it was noted that there was no patient compromise.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.

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: 8416526
• MDR Text Key: 139045736
• Report Number: 2015691-2019-00841
• 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: 02/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CK1206Y04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1