MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR CO-SET PLUS FLOW-TRU HOUSING; PROBE, THERMODILUTION

Model Number 93505

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

As reported, in several occasion during use in patient, this manifold broke.There was no allegation of patient injury.The devices were not available for evaluation.

Manufacturer Narrative

No product was returned for evaluation; it was discarded at the hospital.Without the return of the product, it is not possible to determine if damages or defects existed on the product, nor could a root cause or potential contributing factors be identified.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.

• Brand Name: CO-SET PLUS FLOW-TRU HOUSING
• Type of Device: PROBE, THERMODILUTION
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haiana, san cristobal ; DR
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haiana, san cristobal ; DR
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 19213004
• MDR Text Key: 341683667
• Report Number: 2015691-2024-03228
• Device Sequence Number: 1
• Product Code: KRB
• UDI-Device Identifier: 07460691949973
• UDI-Public: (01)07460691949973(17)270605(11)220606(10)64390628
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K833997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/30/2024

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 Model Number: 93505
• Device Lot Number: 64390628
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/08/2024
• Initial Date FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/06/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1