MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE INSTRUMENT

Model Number HEM1

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/23/2019

Event Type  malfunction  

Manufacturer Narrative

The hemosphere instrument will not be returned for evaluation as the exact product cannot be identified.The serial number of the product is unknown.The device service history record review could not be completed as the serial number is unknown.Edwards is unable to confirm or negate the customer¿s experience without the return of the suspect device.The root cause of the reported issue is indeterminable as the product was not evaluated.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.(b)(4).

Event Description

It was reported that during patient monitoring with the hemosphere 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

The swan ganz module product involved in this event was reported under submission number 2015691-2019-03068.

Manufacturer Narrative

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

• Brand Name: HEMOSPHERE INSTRUMENT
• Type of Device: HEMOSPHERE INSTRUMENT
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 8903426
• MDR Text Key: 155205117
• Report Number: 2015691-2019-03069
• 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: user facility
• 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 Model Number: HEM1
• Device Catalogue Number: HEM1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1