MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PKG ASSY, SWAN-GANZ; HEMOSPHERE SWAN GANZ MODULE

Model Number HEMSGM10

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

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

Event Date 12/20/2022

Event Type  malfunction  

Manufacturer Narrative

The product has been requested to be returned for evaluation, but has not yet arrived.When the evaluation has been completed the findings will be submitted in a supplemental report.The device history record review has been completed and all manufacturing inspections passed with no non conformances.

Event Description

It was reported that there was a malfunction with the swan ganz module during patient monitoring.There were inconsistent co/ci readings.They exchanged for different swan catheters and it did not resolve the issue.They exchanged the sg module for troubleshooting.There were no error messages displayed.There is no physical damage apparent.The edwards field representative has attempted to obtain additional information, but has not been successful.There was no inappropriate patient treatment administered.There was no patient harm or injury.The patient demographic information is not available.

Manufacturer Narrative

The device was requested to be returned several times; but did not arrive.The evaluation was unable to be performed, there are no findings.H3 other text : device did not arrive.

Manufacturer Narrative

The product arrived for evaluation and the evaluation was completed.The suspect swan ganz module was connected to known good working components for testing.Monitoring began with a simulator connected.The monitoring duration was over an hour and the cardiac output and cardiac index readings were never inconsistent.A visual inspection of the suspect sg module found that the cco connector was cracked and worn.There were wear marks that indicated that the cco cable was being rotated in the connector, instead of being plugged in straight.The reported issue of inconsistent readings was not confirmed.

• Brand Name: PKG ASSY, SWAN-GANZ
• Type of Device: HEMOSPHERE SWAN GANZ MODULE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: jessica atallah ; one edwards way; irvine, CA 92614 ; 9492500294
• MDR Report Key: 16108715
• MDR Text Key: 308729842
• Report Number: 2015691-2023-09997
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 00690103196993
• UDI-Public: (01)00690103196993(11)200412
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163381
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HEMSGM10
• Device Catalogue Number: HEMSGM10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1