MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE SWAN GANZ MODULE

Model Number HEMSGM10

Device Problems Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/04/2020

Event Type  malfunction  

Manufacturer Narrative

The swan ganz module will not returned for evaluation.The specific unit involved in the event could not be identified.The reported issue could not be confirmed by product evaluation as the product was not received.The device service history record review could not be completed as the correct serial/lot number is unknown.There is no evidence or indication that a manufacturing defect is responsible for the reported issue; therefore, no corrective action was taken.With any hemodynamic monitoring readings can change quickly and dramatically.Clinicians are trained to evaluate the entire clinical presentation of the patient in order to make decisions.In addition, these devices are used by highly trained clinicians experienced in assessing and mitigating any hazards that arise.It could not be confirmed if user or procedural factors contributed to the stated 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 part of the monthly review.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to the complaint.

Event Description

It was reported that there were inaccurate pac measurements that were observed by the clinicians during patient monitoring.The hemosphere instrument (hem1) and the swan ganz module (sgm) were being used.The issue was not isolated to either unit.The edwards clinical field representative visited the facility to investigate.The clinicians were unable to identify which unit had the alleged failure, but they did know that the numbers displayed were inaccurate.The patient parameter numbers displayed and the numbers that were expected are unknown.The serial numbers of the units involved is unknown.The patient demographics are unknown.There will be no product return.There was no inappropriate patient treatment administered.There was no patient harm or injury.The hem1 involved will be reported as an mdr submission.

Manufacturer Narrative

The hem1 instrument involved has been reported as an mdr submission, 2015691-2020-12204.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: HEMOSPHERE SWAN GANZ MODULE
• Type of Device: HEMOSPHERE SWAN GANZ MODULE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 10171121
• MDR Text Key: 197086388
• Report Number: 2015691-2020-12202
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• PMA/PMN Number: K163381
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/04/2020

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: Health Professional
• Device Model Number: HEMSGM10
• Device Catalogue Number: HEMSGM10
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/04/2020
• Initial Date FDA Received: 06/18/2020
• Supplement Dates Manufacturer Received: 06/18/2020; 07/23/2020
• Supplement Dates FDA Received: 06/19/2020; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1