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

Model Number PXVMP260

Device Problems Detachment of Device or Device Component (2907); Pressure Problem (3012); Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/17/2018

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation as 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.Lot or serial number was not provided, therefore review of the manufacturing records could not be completed.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.If the pressure tubing becomes detached during use, it will affect the pressure waveform, which will immediately alert the clinician to begin the troubleshooting process.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 unknown whether user or procedural factors played a role in this 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 in this disposable pressure transducer with a vamp, the arterial tubing detached, allowing air to enter they system.According to the clinician, this provided ¿false pressure measurements¿.Attempts are being made to obtain further information including patient demographics.The device was not available for evaluation since it was discarded.

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: 7749249
• MDR Text Key: 116543917
• Report Number: 2015691-2018-03195
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• PMA/PMN Number: K925638
• 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: 07/11/2018

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: PXVMP260
• Device Catalogue Number: PXVMP260
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/11/2018
• Initial Date FDA Received: 08/03/2018
• 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