MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR TRUWAVE, VAMP; CATHETER, CONTINUOUS FLUSH

Model Number	PXVFP11241
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during set up of this pressure monitoring set, the bonding of the connector and tubing was detached.There was no further information available.There was no patient involvement.
Additional Manufacturer Narrative
The device evaluation is anticipated.However, the complaint cannot not be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming when the investigation is completed, as well as the device history record review results.The lot number is unconfirmed at this time, the production identifier (pi) portion of the udi number is currently unknown.
Additional Manufacturer Narrative
Additional information was received that, the customer has corrected the previously reported event and commented that the event was leakage instead of the connector or tubing detachment.The detailed location of the malfunction within the kit was unknown.Therefore, this is not a reportable event.Furthermore, the product was evaluated and the reported issue of leakage issue was not able to be confirmed.All connections appeared tight as received.No visible damage or inconsistencies were observed from the kit during the visual examination.There was no leakage observed from the kit during the leak test.No luer connections got loose or detached during the evaluation.

• Brand Name: TRUWAVE, VAMP
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• 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: jon diaz ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 20186159
• Report Number: 2015691-2024-06976
• Device Sequence Number: 7059170
• Product Code: KRA
• UDI-Device Identifier: 07460691955097
• UDI-Public: (01)07460691955097
• Combination Product (Y/N): N
• 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: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2024

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
• Operator of Device: Health Professional
• Device Model Number: PXVFP11241
• Device Lot Number: ZF0534MT
• 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: 08/22/2024
• Supplement Date Received by Manufacturer: 09/17/2024
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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