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

Model Number PXVMP120

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 05/30/2017

Event Type  malfunction  

Event Description

An arterial line was placed on this patient.The line was initially working appropriately.After about 15 mins of being in we saw a sudden drop in arterial blood pressure with a very good waveform.We had just given sedation and paralyzing medication and attributed the drop in pressure to that.We started levophed and a bolus of fluid with no change to the pressure.A cuff pressure showed a normal to hypertensive blood pressure.This did not seem overly surprising to us because the patient's blood pressure had been labile prior to admission.We started vasopressin; this also had no affect on the blood pressure.At this point we began to question the arterial line so we changed to pressure cable connecting it to the monitor.This resulted in a complete loss of the waveform.The line continued to flush and draw appropriately and the patient had palpable pulses.We decided to replace the pressure tubing, including the transducer.The new tubing immediately worked correctly and correlated with the cuff blood pressure.

• Brand Name: TRUWAVE, VAMP
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 6617836
• MDR Text Key: 76849776
• Report Number: 6617836
• Device Sequence Number: 0
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 02/27/2019
• Device Model Number: PXVMP120
• Device Catalogue Number: PXVMP120
• Device Lot Number: 60719479
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/30/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 05/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CARDIAC DRUGS
• Patient Age: 42 YR
• Patient Weight: 159