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

Model Number PXMK10261

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 device evaluation is anticipated.The complaint cannot not be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation however, the lot number was not provided thus a device history record was not reviewed.

Event Description

It was reported that arterial blood pressure value was inaccurate during use.The systolic blood pressure value shown on the monitor was between 40 and 50mmhg, while the expected values was 200mmhg.No treatment based on the incorrect value was performed.The dpt was able to be zeroed before use.The customer performed flushing as a troubleshooting but it did not help.The data log was not provided.The device was exchanged and the problem was solved.Patient demographic information requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

One single disposable pressure transducer kit with an iv set and pressure tubing was returned for evaluation.Pressure tubing remained coiled with paper band, and was disconnected from the dpt when received.The reported event of inaccurate pressure reading was not able to be confirmed during evaluation, however, zeroing and sensing issues were observed.The dpt did not zero nor sense pressure on the pressure monitor.Electrical testing showed that output impedance was out of specifications, and the input circuit was in an open condition.A crack was observed on the sensor chip inside the dpt.The crack ran across the entire sensor chip and affected both input and output circuits.No visible damage or defect was observed at solder joints, cable connector, and the cable of dpt.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: samantha eveleigh ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 12586884
• MDR Text Key: 275170315
• Report Number: 2015691-2021-05537
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K925638
• 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: 11/24/2021

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 Model Number: PXMK10261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/17/2021
• Initial Date FDA Received: 10/06/2021
• Supplement Dates Manufacturer Received: 11/05/2021
• Supplement Dates FDA Received: 11/23/2021
• 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