MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR PRESSURE MONITORING ACCESSORY; STAND, INFUSION

Model Number TCLIP05

Device Problems Incorrect Measurement (1383); Device Difficult to Setup or Prepare (1487)

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

Event Date 04/18/2022

Event Type  malfunction  

Manufacturer Narrative

Follow up is on going to clarify whether the device is available for evaluation.An investigation will be completed to consider any potential factors that may have contributed to this complaint and a supplemental report will be sent with the investigation results.Device has not been received.

Event Description

As reported, during use in patient with this flotrac sensor, inaccurate values were measured.It could not be confirmed whether there was a problem with the sensor, or the iv pole.There was no further information available regarding this case.There was no allegation of patient injury.Patient demographics requested but unable to be obtained.Follow up is on going to clarify whether the device is available for evaluation.

Manufacturer Narrative

One flotrac sensor was received by our product evaluation laboratory for a full examination.The report of pressure readings issue was unable to be confirmed.Both flotrac and dpt sensors of the flotrac unit zeroed and sensed pressure accurately on ev1000 and pressure monitor.No error message was noticed on the monitors.During flotrac and dpt pressure output drift testing, pressure did not show any drift and met specification.Electrical testing showed that both input and output impedance for both flotrac and dpt sensors were within specifications.Zero-offset for both sensors also met specification.No leakage or occlusion was detected from the kit during pressure test.No visible damage was observed from the kit.The lot number for this device was not supplied; therefore, further review of the related manufacturing records could not be performed.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

Initially, this event was reported against a flotrac sensor that was received for evaluation and tested on (b)(6) without any failure found.As per customer clarification on the follow up, the inaccurate values issue was due to the truclip holder (ref.(b)(4)) movement down on the pole and there was no malfunction with the flotrac disposable.Based on this information and on the flotrac evaluation results, this file has been updated from flotrac to truclip holder (ref.(b)(4)).Additionally the event description has been updated as follows: as reported, during use in patient, this truclip holder moved down on the pole causing an inaccurate values measurement when used with a flotrac sensor.It was confirmed that there was no malfunction with the flotrac disposable.There was no further information available regarding this case.There was no allegation of patient injury.The truclip involved in this case has been discarded at hospital and not being used anymore.The flotrac sensor involved in this case was sent for evaluation even though as per follow-up information, the issue was related to the truclip.Device related fields in section d and investigation codes were updated in in their respective fields.This device is exempt of 510k reference.It was further informed that the truclip involved in this case was not available for evaluation, since it has been discarded at hospital and not being used anymore.Without return of the product, edwards is unable to perform a complete investigation of the reported event.It is not possible to determine what factors may have contributed to it, and therefore no actions could be planned.The lot number for this device was not supplied; therefore, further review of the related manufacturing records could not be performed.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: PRESSURE MONITORING ACCESSORY
• Type of Device: STAND, INFUSION
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina , san cristobal
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina , san cristobal
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 14427501
• MDR Text Key: 291956994
• Report Number: 2015691-2022-05733
• Device Sequence Number: 1
• Product Code: FOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/20/2022

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: TCLIP05
• Device Catalogue Number: MHD6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/18/2022
• Initial Date FDA Received: 05/18/2022
• Supplement Dates Manufacturer Received: 06/02/2022; 07/05/2022
• Supplement Dates FDA Received: 06/22/2022; 07/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1