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

Model Number PXVMP120

Device Problems Contamination (1120); Device Contamination with Body Fluid (2317); Failure to Clean Adequately (4048)

Patient Problem Unspecified Infection (1930)

Event Date 08/20/2019

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation; it was discarded at the hospital.Without return of the unit it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.Lot number was not provided; therefore, review of the manufacturing records could not be completed.Invasive procedures do involve some patient risks.Although serious complications are relatively uncommon, the physician is advised to consider the potential benefits in relation to the possible complications.At this time it is unknown what catheters were cultured and what pathogens were found.Upon investigation at the facility, it was discovered that the clinicians were cleaning the z-sites for approximately 6 seconds, or just a swipe with the alcohol swab, versus the hospital policy recommendation of 30 seconds.It is noted in the ifu to: swab the vamp needleless sampling site with disinfectant such as alcohol or betadine, depending on hospital policy.In addition, the ifu states: positive cultures can result from contamination of the pressure setup.Increased risks of septicemia and bacteremia have been associated with blood sampling, infusing fluids, and catheter related thrombosis.There is a potential that user factors played a role in the stated event.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 part of this monthly review.

Event Description

It was reported that during use of this vamp system in an arterial line, an infection was noted.The customer¿s opinion is that the infection is happening through the z-site, where blood is drawn from the arterial line.Per a hospital investigation, the clinicians were not swabbing the z-site for the appropriate amount of time before drawing the blood from the sample site.The device was discarded at the hospital.Follow up attempts were made for information on patient demographics and any additional information without success to date.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: PRESSURE MONITORING KIT
• 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 ; DR
• MDR Report Key: 9037098
• MDR Text Key: 161262198
• Report Number: 2015691-2019-03423
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• PMA/PMN Number: K925638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PXVMP120
• Device Catalogue Number: PXVMP120
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other