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

Model Number DPTUNKNOWN

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Type  malfunction  

Event Description

It was reported that icu staff have had discrepancies between arterial line readings and manual cuff readings since (b)(6) 2022.The values on the arterial line were consistently higher compared to the manual cuff readings.There were at least 35 patients with invasive blood pressure issues -ibp, and each were using a truwave transducer.Different lots were used and numbers are unknown, but models used are px284 and pxvp2284, quantity of each is unknown, patient demographics and date of occurences are not provided.Staff tried to troubleshoot by ensuring there was no air in tubing or transducer, the stopcocks were in the appropriate positions, the connections were tight without cracks or leaks, the pressure bag has normal saline and was inflated to 300mmhg, the transducer was leveled and re-zeroed, the line was aspirated and flushed, excess tubing was removed, and that the square wave was checked.The kits were primed via gravity.There was no abnormal wave form or error messages.Hospital investigated the issue themselves.In the investigation, troubleshooting was provided to swap the ibp cable and nibp tubing with the cuff and the issue was not resolved.The truwave transducers were then tested in the biomed shop and showed accurate pressures.Philips tested icu rooms with biomed configuration.All tests came back with no issues and confirmed the settings were good.Nibp was tested with biomed and passed all functional tests.Manual bp checks were also performed by nurses and matched the philips monitor.A zoll defibrillator, hemosphere, and philips transport monitor were next tested.Ibp and nibp matched one of the icu patient monitors.Between the different monitors, the transducer was the common denominator.All events occurred during use.There were no patient injuries, but unintended treatments such as prn anti-hypertensive medications were administered.Of the 35 devices being reported, only 3 will be returned, but it is unclear which models.This report is for one of the 3 devices expected to be returned.

Manufacturer Narrative

The product is expected to be returned for analysis but has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.Complaint histories for all reported events are reviewed against trending control limits, and any excursions above the control limits are assessed and documented as part of this monthly review.H3 other text : pending product return.

Manufacturer Narrative

A supplemental mdr is being submitted due to the product investigation findings.Sections g6, h2 and h6 - type of investigation findings, investigation findings and investigation conclusions have been updated.Our product evaluation lab received one single dpt - vamp plus kit.The customer report of pressure discrepancies was not able to be confirmed.No visible damage was observed from the returned kit.Dpt sensor zeroed and sensed pressure accurately on hemosphere monitor.No error message was observed on the monitor.The pressure did not show any drift during output drift testing and met specification.The electrical testing showed that both input impedance (2,229 ohms) and output impedance (303 ohms) of dpt sensor were within specifications.Specifications were 1,200 ohms to 3,400 ohms for input impedance and 285 ohms to 315 ohms for output impedance per drawing 270378 rev.T.Zero-offset (-3 mmhg) also met specification per drawing 270378 rev.T (vex = 6.00011 v and vo = -0.0000769 v).Specification was -25 mmhg to 25 mmhg per drawing 270378 rev.T.No leakage or occlusion was detected from returned kit during pressure test.Further engineering investigation for this unit does not require to be performed since the defect related to dpt system - inaccurate values was not confirmed during product evaluation (no defect found).Complaint histories for all reported events are reviewed against trending control limits, and any excursions above the control limits are assessed and documented as part of this monthly review.

• Brand Name: PRESSURE MONITORING SET
• 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: katheryn richards ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 18465351
• MDR Text Key: 332749168
• Report Number: 2015691-2024-00146
• 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: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DPTUNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/21/2024
• 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