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

Model Number T001691A

Device Problems Fluid/Blood Leak (1250); Device Contamination with Chemical or Other Material (2944)

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

Event Date 04/27/2020

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, before use in patient, with this pressure monitoring set, there was fluid droplets noted inside the pressure tubing before the set was connected to the saline bag.There was no allegation of patient injury.The device was available for evaluation.Patient demographics are not available.

Manufacturer Narrative

The reported event of fluid droplets noted inside the pressure set tubing was not confirmed.Visual examination of the kit both before and after decontamination did not find any presence of foreign substance or liquid inside the kit.The kit was flushed out after decontamination to a filter paper for 5 minutes for further examination.There was no visible foreign substance on filter paper.  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.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.

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: 10076956
• MDR Text Key: 193425589
• Report Number: 2015691-2020-11908
• 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,Followup
• Report Date: 04/29/2020

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: 10/08/2021
• Device Model Number: T001691A
• Device Lot Number: 62579704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2020
• Initial Date Manufacturer Received: 04/29/2020
• Initial Date FDA Received: 05/20/2020
• Supplement Dates Manufacturer Received: 06/08/2020; 07/23/2020
• Supplement Dates FDA Received: 06/15/2020; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1