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

Model Number PX260

Device Problems Contamination of Device Ingredient or Reagent (2901); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/23/2017

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 confirm the reported event.Lot number was not provided, therefore review of the manufacturing records could not be completed.It is common clinical practice to inspect all products before usage.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.In this case there was no patient involvement.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 when flushing this disposable pressure transducer (dpt), a foreign body was found inside of the fluid path.It is unknown if it was intravenous or the pressure line.Replacing the device solved the issue.There was no patient injury.Unfortunately, device was not available for evaluation.

Manufacturer Narrative

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

• Brand Name: PRESSURE MONITORING KIT WITH TRUWAVE DISPOSABLE PRESSURE TRANSDUCER
• 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: 8504191
• MDR Text Key: 141751520
• Report Number: 2015691-2019-01258
• 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: 03/20/2019

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: PX260
• Device Catalogue Number: PX260
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/20/2019
• Initial Date FDA Received: 04/11/2019
• Supplement Dates Manufacturer Received: 07/23/2020
• Supplement Dates FDA Received: 11/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR