MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE ADVANCED MONITOR; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number HEM1

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2017

Event Type  malfunction  

Manufacturer Narrative

The device return remains pending; a supplemental report will be submitted to communicate the results of the evaluation, investigation and review of the manufacturing/service records.

Event Description

It was reported that during use of a hemosphere monitor, the central venous pressure (cvp) value was dissimilar to the values obtained with a philips bedside monitor.The bedside monitor showed a continuous cvp of 8-11mmhg, while the hemosphere showed a static value of 2 mmhg.No alarm nor error message was displayed.The patient subsequently expired; however, the edward's device was exempted as a contributing factor.Patient demographics were requested but were unable to be provided.No other system-related devices were identified as suspect.

Manufacturer Narrative

Review of the manufacturing records support that there were no non-conformances noted during the manufacturing of the device and all specifications were met prior to release.A review of the service history supports that there have been no issues requiring servicing prior to this report.The initial report stated that the device was expected to be returned and evaluated.However, the response after subsequent return requests indicated that no further information would be provided.Additionally, the return of the device is no longer expected to be forthcoming.With any hemodynamic monitoring, pressure readings can change quickly and dramatically.Clinicians are trained to evaluate the entire clinical presentation of the patient in order to make such decisions.In addition, these devices are used by highly trained clinicians experienced in assessing and mitigating any hazards that arise.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 a part of the monthly review.

Manufacturer Narrative

Additional information was received regarding this event: the european marketing manager visited the site, and after troubleshooting, determined that the discrepancy in the values between the bedside monitor and the hemosphere were due to an incorrect set-up performed by the end user.During initiation, the customer failed to execute the voltage set-up in accordance with the requirements for analog input, as directed in the operator's manual.The marketing manager subsequently instructed the customer on the proper the set-up.Although the device was not returned after the source of failure was identified, the device was later removed, as the evaluation period was completed.

• Brand Name: HEMOSPHERE ADVANCED MONITOR
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• Manufacturer Contact: lynn selawski ; 1 edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 7140801
• MDR Text Key: 95798201
• Report Number: 2015691-2017-04478
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K163381
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/04/2017

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 Expiration Date: 10/01/2022
• Device Model Number: HEM1
• Device Catalogue Number: HEM1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/04/2017
• Initial Date FDA Received: 12/21/2017
• Supplement Dates Manufacturer Received: 02/22/2018; 03/13/2018
• Supplement Dates FDA Received: 03/06/2018; 03/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2017
• 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