MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR UNKNOWN DPT; 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

Multiple attempts were made to secure return of the device however the customer has not responded nor sent the device back for evaluation.Without return of the unit it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.It is not known if some procedural factors may have contributed to the event.No corrective actions will be taken at this time.Further evaluation regarding supplier 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 multiple pressure monitoring devices had inaccurate blood pressure measurements.Readings were 30 mmhg higher or lower than noninvasive measurements.Customer believes the devices had severely under dampened tubing which caused the inaccurate readings.Anesthesiologists began having multiple incidents of inaccurate blood pressure measurements from june 1 to present.Total quantity and lot numbers were unknown.No error message was displayed on the nihon kohden monitors, but the arterial line waveform showed multiple dicrotic notches.Nibp was measured on both upper extremities on the reported incidents.There was minimal difference in nibp between the extremities.Cables have been ruled out as a possible cause.Issue was resolved by removing all vamp arterial lines and replacing with the original arterial line set up.There were no patient injuries.

Manufacturer Narrative

Per follow up with customer, the multiple dicrotic notches alerted clinicians that the tubing and waveforms were severely underdampened.The clinicians believe the underdampened tubing and waveform gave the falsely elevated sbp measurements.Per decision rationale matrix, damped waveform on a pressure monitoring device is not reportable; therefore this is no longer a reportable event.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

Per follow up with customer, it was reported the anesthesiologists began having multiple incidents of inaccurate blood pressure measurements from june 1 to present.Total quantity and lot numbers are unknown.Nibp was measured on both upper extremities on the reported incidents.There was minimal difference in nibp between the extremities.Inaccurate values were seen after multiple successful zeroing steps.Cables have been ruled out as a possible cause.Issue was resolved by removing all vamp arterial lines and replacing with the hospital original arterial line set up.Customer confirmed the tubing and lines were used on the same insertion site.No error messages were displayed on the nihon kohden monitors, but the arterial line waveform showed multiple dicrotic notches.The multiple dicrotic notches alerted clinicians that the tubing and waveform were severely under dampened, which the clinicians believe gave the falsely elevated sbp measurements.Multiple attempts for model were made, but received no response from customer.

• Brand Name: UNKNOWN DPT
• 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: 14949390
• MDR Text Key: 304410921
• Report Number: 2015691-2022-06655
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/05/2022

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: DPTUNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/17/2022
• Initial Date FDA Received: 07/07/2022
• Supplement Dates Manufacturer Received: 07/18/2022
• Supplement Dates FDA Received: 08/05/2022
• 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