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

Model Number PXMK10656

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

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

Event Date 09/16/2021

Event Type  malfunction  

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.A device history record review was completed and documented that device met all specifications upon distribution.

Event Description

It was reported that although arterial blood pressure was observed for a brief second, it gradually moved down and eventually became unable to be observed on the first day of use.The catheter and the pressure monitoring set were replaced and the problem was solved.Both of the devices were used for the same patient.No abnormal waveform was observed.The patient was not treated based on the incorrect value.Dpt zeroed before use.The data log was not provided.There was no occlusion, leakage or kink noted.The patient demographic information requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

One single flothru dpt kit with pressure tubing.The reported event of pressure measurement issue was not able to be confirmed.Dpt zeroed and sensed pressure accurately on pressure monitor.Electrical testing showed that both input impedance and output impedance were within specifications.Zero-offset (0 mmhg) also met specification.Further evaluation showed that the dpt passed the pressure test and the pressure reading was also stable during 8 hours of output drift test.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: DISPOSABLE PRESSURE TRANSDUCER 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: 12682284
• MDR Text Key: 278823320
• Report Number: 2015691-2021-05864
• 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: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/14/2021

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 Expiration Date: 08/06/2023
• Device Model Number: PXMK10656
• Device Lot Number: PK1219MT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/01/2021
• Initial Date FDA Received: 10/22/2021
• Supplement Dates Manufacturer Received: 11/23/2021
• Supplement Dates FDA Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2021
• 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