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

Model Number PXVFL11054

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 02/08/2022

Event Type  malfunction  

Event Description

It was reported that backflow of blood on a pressure monitoring set was observed during use.Blood flowed backward to the second lass from the distal end when the customer was not performing any procedure, such as drawing the clearing volume.No blood leakage was observed.The patient was an adult.There were no patient complications reported.Additional information was obtained from malfunction report provided by the customer.It was reported that the arterial blood pressure waveform on the monitor suddenly stopped during use.The customer confirmed that it was able to draw and reinfuse the clearing volume, and flush the line by pulling the pull tab at this time.While the customer was checking each connector, line could not flush although the handle of the lass was in the prime, clear position.When the customer flushed saline from the vamp flex reservoir, saline leakage was observed from the septum of the first lass from the distal end.The arterial line was removed and reinserted.Possible lot number has been added since the pouch contained the device was discarded at the hospital.Additional information was obtained from the sales rep.Visual examination by the sales rep confirmed that an indwelling needle was included in the returned device.Through follow-up with the sales rep, it was confirmed that further information regarding if a new insertion site was required could not be obtained.

Manufacturer Narrative

The device evaluation is anticipated.However, the complaint cannot not be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation and device history results when received.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.

Manufacturer Narrative

Customer report of leakage issue, pressure measurement issue, and occlusion issue were not able to be confirmed during evaluation.As received into lab, all connections appeared tight.Note that distal end of pressure line was occluded with dry blood as received in deco lab, and the blood was removed during decontamination.It was able to prime throughout the kit without indication of occlusion or flow restriction.It was also able to flush entire kit without any problem.Flush device functioned properly.No visible defect was observed from flush device.There was no visible indication of occlusion or restriction on entire kit.No leakage was also observed from the entire kit during leak test.Dpt zeroed and sensed pressure accurately on pressure monitor.Electrical testing showed that both input impedance, 2192 ohms, and output impedance,300 ohms, were within specifications.Specifications were 1200 ohms to 3400 ohms for input impedance and 285 ohms to 315 ohms for output impedance per drawing 270378 rev.T.Zero offset, 0 mmhg, also met specification per drawing 270378 rev.T, vex equals 6.001v and vo equals negative 0.000001 v, spec.Was from neg.25 to pos.25 mmhg.No visible defect was found from dpt cable connector.Further evaluation regarding supplier related quality issues is under investigation.A device history record review was completed and documented that device met all specifications upon distribution.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: jonathan diaz ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 13641318
• MDR Text Key: 286505090
• Report Number: 2015691-2022-04214
• 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: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/12/2022

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 Expiration Date: 10/27/2023
• Device Model Number: PXVFL11054
• Device Lot Number: PT0413MT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/15/2022
• Initial Date FDA Received: 03/01/2022
• Supplement Dates Manufacturer Received: 03/28/2022
• Supplement Dates FDA Received: 04/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2021
• 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