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 Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 07/23/2019

Event Type  malfunction  

Manufacturer Narrative

The product has not arrived for evaluation.Once the product has been evaluated a supplemental submission will be sent with the evaluation findings.The device history record review was completed and all manufacturing inspections passed with no non-conformance's.The record of servicing has been reviewed and there is no previous related record.The udi number is (b)(4).

Event Description

It was reported that during patient monitoring with the hemisphere instrument and swan ganz module that there were inaccurate cardiac output readings.The co readings were 1.1 l/min.The physician did not feel the reading was accurate based on the patient¿s condition.The physician performed an ultra sound quick view of the heart and an echo and determined it was not accurate.The hem1 monitor and sg module were replaced and the co reading was 2.0.This was reflective of the patient¿s condition.An open heart surgery had been performed on a female patient, (b)(6) years old.There was no inappropriate patient treatment administered.There was no patient harm or injury.

Manufacturer Narrative

One swan ganz module was received for product evaluation.The suspect product was connected to a known good working hemosphere instrument for analysis and testing.The system verification test was performed and left to run for over 30 minutes.The co values remained within appropriate parameters.There were no error messages observed.A visual inspection was performed and there was no physical damage identified.There was no defect found.The reported event was not confirmed by evaluation.There is no evidence or indication that a manufacturing defect is responsible for the reported issue; therefore, no corrective action was taken.There was no inappropriate patient treatment administered.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 is unknown 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.The hemosphere instrument (hem1), that was linked with this sg module, submission number is 2015691-2019-03069.The hem1 instrument was not returned for evaluation as the exact product used with this sg module is unknown.There are no product results available.

Manufacturer Narrative

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: 8903403
• MDR Text Key: 196271063
• Report Number: 2015691-2019-03068
• 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: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/09/2023
• Device Model Number: HEMSGM10
• Device Catalogue Number: HEMSGM10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1