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

Model Number T100209B

Device Problems Complete Blockage (1094); Difficult to Flush (1251)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2018

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation; it was discarded at the hospital.Without return of the unit it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.No corrective actions will be taken at this time.A review of the manufacturing records indicated that the product met specifications upon release.Invasive procedures involve some patient risks.Although serious complications are relatively uncommon, the physician is advised, before deciding to insert an arterial line, to consider the potential benefits in relation to the possible complications.In this case, the patient required a new stick to insert a new catheter for an arterial line.It is unknown if user or procedural factors may have contributed to this event.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 with this dpt (disposable pressure transducer), flushing was not possible due to blood clotting.The occlusion was in the area of the three way stopcock.This resulted in a blocked arterial line making blood sampling unobtainable.Due to this issue, the access line required a new insertion site.Patient demographics were requested, but not available.There was no allegation of patient injury.The device was discarded at the hospital.

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: 8134955
• MDR Text Key: 130346546
• Report Number: 2015691-2018-05096
• 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: 11/17/2018

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 Expiration Date: 06/04/2020
• Device Model Number: T100209B
• Device Catalogue Number: T100209B
• Device Lot Number: 61425545
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/17/2018
• Initial Date FDA Received: 12/05/2018
• 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