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

Model Number T001691A

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 12/16/2020

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 that after opening the package, in this pressure monitoring set, it was discovered that there was liquid inside the dip chamber.The device was replaced.There was no allegation of patient injury.The device was available for evaluation.Since this was before use, patient demographics are not available.

Manufacturer Narrative

One single dpt with vamp plus was received for evaluation.The reported event of liquid inside the drip chamber was not confirmed.Paper tapes were noted on iv tubing.Visual examination of the kit both before and after decontamination did not find any presence of foreign substance or liquid inside the kit.Kit was tried to be drained, no foreign substance or liquid came out on filter paper from draining.Finally, returned kit was primed and flushed without any indication of flow restriction or occlusion.Flush device functioned properly during priming and flushing.No visible damage was observed from the kit.A device history record review was completed and documented that device met all specifications upon distribution.Since the defect was not confirmed, no corrective actions will be taken at this time.

• Brand Name: PRESSURE MONITORING SET
• 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: 11113633
• MDR Text Key: 227070202
• Report Number: 2015691-2021-00009
• 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: 12/16/2020

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: 07/20/2022
• Device Model Number: T001691A
• Device Lot Number: 63317142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2021
• Initial Date Manufacturer Received: 12/16/2020
• Initial Date FDA Received: 01/04/2021
• Supplement Dates Manufacturer Received: 01/13/2021
• Supplement Dates FDA Received: 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1