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

Model Number PXVFP21102

Device Problem Inaccurate Flow Rate (1249)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/08/2022

Event Type  malfunction  

Manufacturer Narrative

All connections appeared tight as received.Damage was observed at handle of zero stopcock on red line.Damage at stopper of the stopcock handle appeared consistent with damage incurred when the stopcock was overturned past 180 degree angle.It was able to prime throughout the kit without problem.No leakage was observed from the kit during leak test.Further evaluation regarding related quality issues is under investigation.The lot number was not provided thus a device history record was not reviewed.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.

Event Description

It was reported that the saline in the infusion bag decreased too fast while pulmonary artery pressure and right atrium pressure were monitored in icu after cardiac catheterization on the first day of use.The amount of infusion dripped into the patient body was 400ml in 13 hours duration from 10p.M.On oct.8th to 11a.M.On oct.9th.Although the customer suspected it decreased fast, they replaced the infusion bag and the pressurized bag with new ones.Then another 400ml of infusion was dripped into the patient body and the infusion bag was replaced again.It was on oct.10th that the customer recognized its anomaly and decided to replace the device, when approximately 200ml of infusion dripping was confirmed.During the 3 days from 8oct to 10oct, 1,000ml in total of infusion was entered into the patient body, though total time was unknown.It was a cardiomyopathy patient and undergoing continuous dialysis, therefore rigorous water management was required.The defected product was inspected in icu and it was confirmed that approximately 150ml of solution was dripped in 5.5 hours from the right atrium port.From this, the customer concluded the flow rate of the swan ganz catheter route on the right atrium side was approximately 30ml over h.The device was exchanged and the problem was solved.The device was exchanged and the problem was solved.There were no patient complications reported.

Manufacturer Narrative

Follow up was completed.Per rep, larger volume of water removal on dialysis treatment was performed for moisture balance adjustment.No health hazard on the patient body was observed.Per additional information, health effect impact code was updated to no.4620 prolonged episode of care.Additional evaluation was completed.Flow rate through red label dpt was measured 2.2 ml per hour, however flow rate through blue label dpt was 8.9 ml per hour.Specification was 3 plus minus 1 ml per hour.Color dye solution was manually injected into the dpt housing to examine flow.Leakage was visually detected across uv bond area between flow restrictor and dpt housing.Further evaluation regarding related quality issues is under investigation.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.

• 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
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer Contact: jessica atallah ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 15746335
• MDR Text Key: 305884471
• Report Number: 2015691-2022-08961
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/23/2022

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
• Device Model Number: PXVFP21102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/17/2022
• Initial Date FDA Received: 11/07/2022
• Supplement Dates Manufacturer Received: 11/09/2022
• Supplement Dates FDA Received: 11/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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