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  

Manufacturer Narrative

The 32 of 35 devices are not available for return.Without the return of the product, it is not possible to determine if damages or defects exist on the product, nor can any manufacturing nonconformance, failure mode, root cause, or potential contributing factors be identified.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.

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 and it is unclear which models will be returned.This report is for the 32 devices not being returned.

• 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 ; DR
• Manufacturer (Section G): EDWARDS LIFESCIENCES, DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal ; DR
• Manufacturer Contact: jessica atallah ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 18484900
• MDR Text Key: 332981154
• Report Number: 2015691-2024-00237
• 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
• Report Date: 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2024
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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