MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE INSTRUMENT

Model Number HEM1

Device Problems Incorrect Measurement (1383); High Readings (2459)

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

Event Date 07/30/2019

Event Type  malfunction  

Manufacturer Narrative

The product has not been received for evaluation.Once the product is returned and evaluated a supplemental report will be submitted with the evaluation findings.The device history record review has been completed and all manufacturing inspections passed with no non-conformances.The record of servicing was reviewed and there are no previous records.The udi is (b)(4).

Event Description

It was reported that a hemosphere instrument (hem1 monitor), swan ganz module and cable were in use during patient monitoring when the cardiac output and cardiac index readings were ¿abnormally high¿ for the patient¿s condition, per the clinician.The ci reading was 6.7.The monitor, cable and sg module were exchanged for other equipment and the readings were down to normal.A swan ganz catheter was in use with the patient and was not exchanged and was eliminated as a contributor.There was no inappropriate patient treatment administered.There was no patient harm or injury.The patient demographic information is not available.

Manufacturer Narrative

One hemosphere instrument hem1 was received for product evaluation.The suspect hem1 instrument was connected to a sg module and oximetry cable for testing.The system verification test was left to run for over an hour.The co and sv02 values remained within appropriate parameters for the entire testing.A visual inspection was performed and there was no physical damage identified.The modules board was updated from rev5 to rev6.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.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.

Manufacturer Narrative

The submission numbers for the swan ganz module and 70cc2 cable involved are 2015691-2019-03121 and 2015691-2019-03122.The product has not been received for evaluation.Once the product has been received a supplemental report will be submitted with the evaluation findings.

Manufacturer Narrative

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: 8922599
• MDR Text Key: 196411205
• Report Number: 2015691-2019-03120
• 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,Followup
• Report Date: 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/19/2023
• Device Model Number: HEM1
• Device Catalogue Number: HEM1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1