MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CLEARSIGHT PRESSURE CONTROLER KIT; SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

Model Number PC2K

Device Problems Incorrect Measurement (1383); Pressure Problem (3012)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 11/22/2019

Event Type  malfunction  

Manufacturer Narrative

The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results as well as the device history record.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.

Event Description

It was reported that, during preventive maintenance of this pressure controller, the pressure value for cuff 1 measured: 210 mmhg, while the specification should be 300 mmhg.There was no patient involvement in this case.The product was available for evaluation.

Manufacturer Narrative

The pressure controller kit was returned for evaluation but was unable to be evaluated for inaccurate values.There was an inability to plug in a finger cuff into port 1, due to the connector being damaged.It was pushed back on one side and had multiple fractured solder joints and pads pulled from the board.The device history record was reviewed; no related non-conformances were found.There is no escalation is required.With any hemodynamic monitoring, pressure readings can change quickly and dramatically.Cardiac output readings should correlate with the patient¿s clinical manifestations.These devices are used by highly trained clinicians experienced in assessing and mitigating any hazards that arise.These devices are typically used in intensive care units or operating rooms where patients are closely monitored.It is unknown whether any user or procedural factors contributed to this reported event.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: CLEARSIGHT PRESSURE CONTROLER KIT
• Type of Device: SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 9485126
• MDR Text Key: 188696108
• Report Number: 2015691-2019-04720
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• PMA/PMN Number: K140312
• 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: 11/22/2019

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: 03/12/2020
• Device Model Number: PC2K
• Device Catalogue Number: PC2K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Initial Date Manufacturer Received: 11/22/2019
• Initial Date FDA Received: 12/17/2019
• Supplement Dates Manufacturer Received: 02/13/2020; 07/23/2020
• Supplement Dates FDA Received: 02/18/2020; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1