MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR TRUWAVE DISPOSABLE PRESSURE TRANSDUCER WITH 1 FOOT CABLE; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number PX601

Device Problem Fluid/Blood Leak (1250)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 12/13/2022

Event Type  malfunction  

Event Description

It was reported csf leaked from a transducer.Entire duet system and transducer were replaced.No patient injury reported.Device is available for return, but lot number is unknown due to staff discarding packaging.

Manufacturer Narrative

The device evaluation is anticipated.However, the complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation when received.The lot number was not provided thus a device history record was not reviewed.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

The reported event of leakage issue was confirmed.Leakage occurred at connection between dpt housing female luer and attached combicap.No visible defect or damage was observed from the dpt housing female luer and the combicap.Dpt housing female luer passed iso standard.It was noted that the combicap stopped at dpt housing and could not be further tightened.The length of dpt housing female luer was measured 0.2960 inches which was within specification.The combicap was from no.1 mold cavity.Further evaluation regarding related quality issues is under investigation.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

An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.A product risk assessment was generated since this issue is a confirmed product nonconformance.Additionally, a capa was opened to identify the possible root cause of this condition.A conclusion is not available yet.Updates to the h6 codes are as follows investigation findings was changed to leakage seal and investigation conclusions was changed to conclusion not yet available.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.

• Brand Name: TRUWAVE DISPOSABLE PRESSURE TRANSDUCER WITH 1 FOOT CABLE
• 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: jonathan diaz ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 16042879
• MDR Text Key: 306450416
• Report Number: 2015691-2022-10322
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K925638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/08/2023

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 Model Number: PX601
• Device Catalogue Number: PX601
• 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: 12/13/2022
• Initial Date FDA Received: 12/23/2022
• Supplement Dates Manufacturer Received: 01/12/2023; 06/07/2023
• Supplement Dates FDA Received: 02/01/2023; 06/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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