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

Model Number PX260

Device Problem Inaccurate Flow Rate (1249)

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

Event Date 09/26/2021

Event Type  malfunction  

Manufacturer Narrative

An investigation has been initiated to consider any potential factors that may have contributed to this complaint.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.

Event Description

As reported, during use in pediatric patient with this disposable pressure transducer, there was unknown problems during the nigh shift.Troubleshooting was done but the issue remained.During the following dayshift the issue could be solved after dressing was taken down and dpt flushed minimally.However, after taking a blood sample the dpt was flushed and it was realized that flushing process was slower than usual.Then, upon inspection of the device, it was noticed the 500ml saline bag that had been changed the previous dayshift (around noon) was almost empty, with only 100ml, which was 340ml less than expected.There was no leakage on the bed or floor.The dpt and pressure bag was replaced for a new one.Patient did not appear puffy or fluid overload and a blood sample was taken and parameters were normal (pii/inr, cbc, fibrinogen).The customer was unable to establish whether the art line was previously disconnected and flushed resulting in the missing fluid.Patient demographics unable to be obtained.There was no allegation of patient injury.Follow up is on going to clarify whether the device is available for evaluation.

Manufacturer Narrative

It was further informed that the device was not available for evaluation.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.Based on further engineering investigation there are manufacturing controls to avoid potential causes related to the reported malfunction 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: DISPOSABLE PRESSURE TRANSDUCER 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
• 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
• MDR Report Key: 14184736
• MDR Text Key: 290471408
• Report Number: 2015691-2022-05329
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183413
• 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,Followup
• Report Date: 05/26/2022

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: PX260
• Device Catalogue Number: PX260
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/30/2022
• Initial Date FDA Received: 04/22/2022
• Supplement Dates Manufacturer Received: 05/06/2022
• Supplement Dates FDA Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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