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

Model Number	PXVPZ20917
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 that during use of this pressure monitoring set, blood leakage was observed from the arterial line during the blood sampling.The sampling site and the pressure tubing were suddenly detached.The following information was unable to be obtained: the amount of leakage, whether the patient was an adult or child, whether a blood transfusion or prolonged hospitalization was required.There was no patient injury reported.
Additional Manufacturer Narrative
One vamp plus device was returned for evaluation.The reported issue was confirmed.As received, the pressure tubing was detached from z-site.Bond indication was observed on inserted portion of the detached tubing.There was no other visible inconsistency observed.A leak test could not be performed on the unit since the tubing was fully occluded with clotted blood.The sample was sent for further evaluation.A device history record review was unable to be completed as the lot number is unknown.The lot number for this device was not provided and is unknown, therefore, the full udi number is not available.The primary device identifier (di) number was provided.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.
Additional Manufacturer Narrative
The device was sent to our product evaluation lab for further testing.The detached tubing od, measured 0.1395 near the point of detachment, which was within specification.An engineering evaluation was completed to assess for any manufacturing related processes which could be correlated to the complaint.As part of the complaint investigation process, no specific root cause was identified.

• Brand Name: TRUWAVE, VAMP PLUS
• 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 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: 20186165
• Report Number: 2015691-2024-06977
• Device Sequence Number: 20597781
• Product Code: DXO
• UDI-Device Identifier: 07460691950092
• UDI-Public: (01)07460691950092
• 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): 10/31/2024

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: PXVPZ20917
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2024
• 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: 08/26/2024
• Supplement Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 10/31/2024
• 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