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

Model Number PXVP23X3

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Air Embolism (1697)

Event Type  Injury  

Manufacturer Narrative

The device has not been returned for evaluation.Follow up is being conducted with the facility for return of the device.The complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming if the evaluation is completed.

Event Description

It was reported there was an air embolism during line access with a vamp system.The hospital risk management department is holding the unit and will not share specific information on device model, patient status or events.

Manufacturer Narrative

Medwatch (b)(4) and additional information was received.The registered nurse (rn) was drawing blood sample utilizing vamp plus blood sampling system via brachial artery.The blood flow was slow when obtaining the clearing sample.The rn assessed the line, and no air was noted.The rn then reinfused the clearing volume.The patient then experienced arm tremors with unresponsive episode.A ct scan of the head indicated an embolus in the left side of the brain.The vamp plus system was used on the patient for three days.The customer stated they followed the manufacturers instructions for use (mifu).It was unable to be determined if the pressure line connections were checked regularly for sufficiently tightened connections during use of the system.The patient was discharged to a long-term acute care hospital (ltach).Correction: the brand name (d1) and model number (d4) was updated.

• Brand Name: TRUWAVE, VAMP PLUS
• 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: 17744144
• MDR Text Key: 323382868
• Report Number: 2015691-2023-15915
• 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
• Report Date: 10/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: PXVP23X3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/25/2023
• Initial Date FDA Received: 09/14/2023
• Supplement Dates Manufacturer Received: 10/05/2023
• Supplement Dates FDA Received: 10/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 99 KG