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

Model Number PXMK10202

Device Problems Contamination /Decontamination Problem (2895); Device Contamination with Chemical or Other Material (2944)

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

Event Date 03/23/2020

Event Type  malfunction  

Manufacturer Narrative

One single dpt kit with iv set and pressure tubing arrived.Priming solution was visible throughout the kit.A non-edwards (terumo) syringe was attached at zero-stopcock.The reported event of contamination - white foreign material, was not confirmed.There were no visible particulates or contamination that were observed from the returned kit, including non-ew syringe which was attached at zero-stopcock.The plunger of non-edwards syringe was pushed to closed position and then the fluid path of the returned kit was flushed continuously for 5 minutes, however no visible particulates were flushed out from the kit.Additional evaluation task has assigned to manufacturing site for further investigation.  a device history record review was completed and documented that device met all specifications upon distribution.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.The noted particulate was not confirmed during visual inspection.However, 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 a part of the monthly review.

Event Description

It was reported that a white foreign material was observed in the disposable pressure transducer's syringe when the customer tried to release the air during priming.It could not be identified if the foreign material was from saline solution or in the pressure monitoring kit even though it was found in the syringe.Eventually, the customer had to exchange to another pressure monitoring kit for monitoring.Patient demographic information was requested but is unavailable.There were no patient complications reported.

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: 9955755
• MDR Text Key: 192645671
• Report Number: 2015691-2020-11451
• 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: 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: PXMK10202
• Device Lot Number: LN0438MT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2020
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1