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

Model Number	PX600I
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Additional 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 when the investigation is completed.Model number additional 501(k) is k171996.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.
Event or Problem Description
It was reported that a px600i had leakage.Issue was noticed after connecting the device to an external ventricular drainage and flushing.Leakage was likely saline, but could have been a small amount of cerebral spinal fluid.Upon investigation, the rn discovered that the distal end of the transducer spun freely.At this point, she attempted to tighten the connection but could not.Another set was opened to resolve the issue.There were no patient injuries.
Additional Manufacturer Narrative
One flothru dpt (differential pressure transmitter) with bonded stopcocks was returned for evaluation.The reported issue of leakage and that the transducer spun freely was confirmed.Leakage was detected from the one way stopcock bonded connection with the dpt.The lock nut of the one way stopcock was still bonded to the dpt housing female luer but the male luer had been completely broken.An engineering evaluation was completed to assess for any manufacturing related processes which could be correlated to the complaint.The potential root cause for the issue was attributed to manpower.As part the manufacturing process, 100 percent of the units are visually inspected.A device history record review was completed and documented that device met all specifications upon distribution.

• Brand Name: TRUWAVE
• Common Device Name: 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; 1 edwards way; irvine CA 92614
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 20010948
• Report Number: 2015691-2024-06225
• Device Sequence Number: 7123586
• Product Code: DXO
• UDI-Device Identifier: 07460691957077
• UDI-Public: (01)07460691957077(17)260524(11)240524(10)65763165
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K142749
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2024

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 Expiration Date: 05/24/2026
• Device Model Number: PX600I
• Device Lot Number: 65763165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2024
• Supplement Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown