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

Event Date 01/21/2020

Event Type  malfunction  

Manufacturer Narrative

The product is expected to be returned for product evaluation; but has not yet arrived.When the evaluation findings are available a supplemental submission will be sent.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).An mdr for all 3 products involved will be submitted.The submission numbers will be provided in a supplemental report.

Event Description

It was reported by the clinicians that there were inaccurate svr, cardiac index and continuous cardiac index readings during patient monitoring.The hemisphere instrument (hem1), swan ganz module (sgm) and 70cc2 cable were involved and could not be ruled out as contributors to the issue.The svr reading was between 2900-3500.The ci reading was oscillating between 0.1 to 1.1 and the cci reading was 0.9.They were able to recall the oximetry data without any issues.The patient was administered 1500l of fluid.They powered down the hemisphere system and it was powered back up and then all components worked appropriately.The patient demographic information has been requested but not received.There was no patient harm or injury.

Manufacturer Narrative

The product has arrived for evaluation and the results are pending.When the evaluation findings are available a supplemental submission will be sent.The submission numbers for the other products involved in this event are: 2015691-2020-10464 and 2015691-2020-10465.

Manufacturer Narrative

One hemosphere hem1 instrument was returned for product evaluation.The three products involved in the event were connected for testing; hem1 instrument, sg module and the 70cc2 cable.The system verification test was performed and the testing was left to run for over three hours.The co values remained within appropriate parameters.A visual inspection was performed and there was no physical damage that was identified.There was no defect found.The reported issue could not be confirmed by product evaluation.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.

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: 9689278
• MDR Text Key: 194478938
• Report Number: 2015691-2020-10463
• 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: 01/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/21/2023
• Device Model Number: HEM1
• Device Catalogue Number: HEM1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2020
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 85