MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR DISPOSABLE PRESSURE TRANSDUCER KIT

Model Number PL2210TT

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

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

Event Date 06/29/2021

Event Type  malfunction  

Manufacturer Narrative

One single triple dpt kit with iv set and pressure tubing was returned for evaluation.The reported event of pressure value inaccurate was not able to be confirmed.The dpt zeroed and sensed pressure accurately on pressure monitor.Pressure did not show any drift during output drift testing and met specification.Electrical testing showed that both input impedance and output impedance were within specifications.Zero-offset value also met specification.No visible defect was found from the dpt cable connectors.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 that arterial blood pressure value was inaccurate on the first day of use.Value shown on the monitor was about the same as that of pap, although the numerical value was unknown.Expected value was 200mmhg by means of manchette.The pressure waveform gradually went down.The customer performed manchette measurement and also flushed to troubleshoot.It could be zeroed before use.Only the arterial line was exchanged to a single kit.As for occlusion, leakage, or kink, the customer presumed none of them would have observed since it was able to perform flushing.Philips patient monitor was used.Patient demographic information requested but unavailable.There were no patient complications reported.

• Brand Name: DISPOSABLE PRESSURE TRANSDUCER KIT
• Type of Device: DISPOSABLE PRESSURE TRANSDUCER KIT
• 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: samantha eveleigh ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 12205906
• MDR Text Key: 262917343
• Report Number: 2015691-2021-04267
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/21/2021

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: PL2210TT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/30/2021
• Initial Date FDA Received: 07/21/2021
• 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