MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR PRESSURE MONITORING KIT; ARTERIAL BLOOD SAMPLING KIT

Model Number T005021M

Device Problem Leak/Splash (1354)

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

Event Date 06/25/2021

Event Type  malfunction  

Manufacturer Narrative

The lot number for this device was not supplied; therefore, further review of the related manufacturing records could not be performed.An engineering investigation has been initiated to consider any potential factors that may have contributed to this complaint.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

As reported, during use in patient of this disposable pressure transducer with vamp, the lass valve hanged and no longer closed properly.Blood was sprayed into the nurse,s face and patient was hiv positive.There was no allegation of injury to the nurse, based on test completed.It was specified that the syringe used was a safepico aspirator radiometer (ref (b)(4)).There was no allegation of patient injury.Patient demographics unable to be obtained.The device was not available for evaluation as it was discarded.

Manufacturer Narrative

A video was provided for examination.The report of blood sprays issue was confirmed.The video showed a closeup on a vamp flex system.While the vamp syringe was pushed, a leakage was observed from the septum of the lass valve sampling site.Note that it was recommended by ifu (instructions for use) to move the plunger at rate of 1 second for each ml of clearing volume during aspiration and injection of blood from the reservoir.No other visible inconsistency or damage was found in the provided video.Based on engineering investigation, it can be concluded that the potential root cause of the reported malfunction is related to the user not following ifu.The ifu was reviewed and it was confirmed that it contains clear instructions for cleaning process.Edwards sales representative has trained some users at the site on how to use the product and offered to give additional re-training but users decline since they have already ordered a new model t005021g.

• Brand Name: PRESSURE MONITORING KIT
• Type of Device: ARTERIAL BLOOD SAMPLING KIT
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• MDR Report Key: 12299768
• MDR Text Key: 265788063
• Report Number: 2015691-2021-04591
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• PMA/PMN Number: K183413
• 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: 09/03/2021

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 Operator: No Information
• Device Model Number: T005021M
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/21/2021
• Initial Date FDA Received: 08/10/2021
• Supplement Dates Manufacturer Received: 08/12/2021
• Supplement Dates FDA Received: 09/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1