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

Model Number PXMK20327

Device Problems Disconnection (1171); Detachment of Device or Device Component (2907)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 07/01/2020

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 the bonding connection between dpt and the merit flush device was disconnected during prep before use.There were no patient complications reported.Patient demographics are not available.

Manufacturer Narrative

Two double flothru dpt kits with iv sets and pressure tubing was received for evaluation.The priming solution was not visible throughout the kits.For both samples, the reported event of 'bonding connection between dpt and the merit flush device was disconnected' was not confirmed.However, lock nuts of the merit flush devices, that were supposed to be bonded to the dpt female luers, were able to be turned slightly on both lines of the double kit.Bond indication was observed on screw thread of the dpt female luers at the bond area, however, the bond joint to screw thread of lock nuts of merit flush devices were broken, so that the lock nuts were able to be turned.The connections between male luer of merit flush device and dpt female luer appeared tight although the bond joint was broken.No other visible damage/defect was observed from the kit during visual examination.No leakage was observed from the kit during leak test.No luer connection got loose or disconnected during leak test.A device history record review was completed and documented that device met all specifications upon distribution.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

This complaint was regarding a bonding connection on the dpt.The issue of detachment was not confirmed, however, the connection was loose.The supplier was notified of the loose connector.

Manufacturer Narrative

The incident for detachment was not confirmed.The connector was found to be loose, not disconnected.This case is not reportable and no more follow ups will be made.

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: 10311548
• MDR Text Key: 201061393
• Report Number: 2015691-2020-12636
• 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,Followup,Followup
• Report Date: 07/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• 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: PXMK20327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2020
• Date Manufacturer Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1