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

Model Number PXMK2043

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 11/27/2018

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is anticipated.However the complaint cannot not be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation and device history results when received.

Event Description

It was reported that part of a bug was noted inside the lumen of the disposable pressure transducer tubing during priming.The device was exchanged for a new one, in order to solve the issue.There was no allegation of patient injury.The disposable pressure transducer was available for evaluation.Patient demographics were unable to be obtained.

Manufacturer Narrative

After the complaint assessment, a potential root cause for the voice of customer complaint of a bug inside the lumen of the tubing was traced to a supplier material related condition.According to the drawing the tubing material has pvc compounds.The supplier has been notified about this event.

Manufacturer Narrative

The reported event of contamination inside of the tubing lumen was confirmed.An unknown dark brown particulate was found attached to the inner wall of the red stripe pressure tubing.The particulate was approximately 0.06"x 0.1" in size and 8" distal from the dpt housing.The particulate remained attached to the tubing surface and did not move during 5 minutes of continuous flushing.A review of the manufacturing records indicated that the product met specifications upon release.The ir spectrum of the dark brown particle showed similar absorption characteristics when comparing to pvc like material.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint, including if the pvc material from the chemistry findings is associated with any component of the manufacturing process.A supplemental report will be sent with the investigation results.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.Particulates that are in the fluid path could enter the bloodstream, potentially embolizing and resulting in patient injury or infection.In this case there was no patient injury or complications.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

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: 8174289
• MDR Text Key: 131332302
• Report Number: 2015691-2018-05374
• 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,Followup,Followup
• Report Date: 11/28/2018

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: 04/03/2020
• Device Model Number: PXMK2043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2018
• Initial Date Manufacturer Received: 11/28/2018
• Initial Date FDA Received: 12/18/2018
• Supplement Dates Manufacturer Received: 01/24/2019; 02/21/2019; 07/23/2020
• Supplement Dates FDA Received: 02/07/2019; 02/27/2019; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1