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

Model Number PXMK2041

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)

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

Event Date 09/24/2023

Event Type  malfunction  

Manufacturer Narrative

The product is not expected to be returned for analysis since it was discarded.An engineering investigation will be performed in order to consider any potential factors that may have contributed to this complaint and a supplemental report will be sent with the investigation results.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 patient in a life-threatening emergency, this disposable pressure transducer (dpt) (2024-06126-01) unscrewed when connected to the arterial access.It was necessary to redo the entire assembly of the pressure line by manually continuing the purge on the arterial line in order to prevent it from clogging.To solve the issue, a new device was opened (2024-06126-02), however, it presented the same issue as two of the screw threads were insufficiently screwed.All screw threads were checked before new connection.Patient demographics asked.There was no allegation of patient injury.The devices were not available for evaluation.

Manufacturer Narrative

Updated: h6 (device code, investigation findings, investigation conclusions), h10 (related report numbers).The manufacturing records were reviewed for the lot involved and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.No root cause could be identified since no product sample nor objective evidence was provided for investigation.In addition, reviews of the device history records revealed no indication that a manufacturing non-conformance contributed to the reported complaint.Current risk mitigation(s) include visual inspection by manufacturing personnel, sampling leak test and sampling flow test.

• Brand Name: TRUWAVE DISPOSABLE PRESSURE TRANSDUCER
• 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 ; 9492503939
• MDR Report Key: 18990248
• MDR Text Key: 338900240
• Report Number: 2015691-2024-02389
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 07460691951464
• UDI-Public: (01)07460691951464(17)240607(11)220608(10)64440036
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K222216
• 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: 05/17/2024

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: PXMK2041
• Device Lot Number: 64440036
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/11/2024
• Initial Date FDA Received: 03/28/2024
• Supplement Dates Manufacturer Received: 05/10/2024
• Supplement Dates FDA Received: 05/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2022
• 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