MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE INSTRUMENT; HEMOSPHERE INSTRUMENT MONITOR

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 07/10/2019

Event Type  malfunction  

Manufacturer Narrative

The product has been returned and the evaluation is in progress.Upon receipt of the evaluation results a supplemental report will be submitted with the evaluation findings.The device service history record review is pending and when the results are available a supplemental report will be submitted with the findings.The udi is (b)(4).

Event Description

It was reported that the hemosphere swan ganz module and hemosphere instrument were used during patient monitoring.The patient was received in the or with a swan ganz catheter in place.The cardiac output reading was 0.8 and was an inaccurate reading.There were no error messages noted.The sg module and hem1 instrument were replaced and then the co reading was 6.0, which was a reliable reading, per the clinicians.The swan ganz catheter was ruled out as suspect.The patient was on ¿nitric oxide¿.There was no inappropriate patient treatment administered.There was no patient harm or injury.

Manufacturer Narrative

The mdr was corrected to show the affected device as a hemosphere monitor and not a swan ganz module.One hemosphere hem1 instrument was received for product evaluation.The suspect product was connected to a known good working sg module, pressure cable and oximetry cable for analysis and testing.The system verification test was performed.The co, map and sv02 values were within appropriate parameters.A visual inspection was performed and there was no physical damage identified.There was no defect found.The sg module was returned for evaluation and it was tested and the reported issue could not be confirmed.However, it was found to have physical damage to the cco connector.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 device history record review was completed and all manufacturing inspections passed with no non-conformances.The record of servicing has been reviewed and there is no previous related record.The submission number for the sg module is 2015691-2019-02824.

Manufacturer Narrative

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

• Brand Name: HEMOSPHERE INSTRUMENT
• Type of Device: HEMOSPHERE INSTRUMENT MONITOR
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 8844061
• MDR Text Key: 154112834
• Report Number: 2015691-2019-02825
• 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: 07/15/2019

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: 09/27/2023
• Device Model Number: HEM1
• Device Catalogue Number: HEM1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2019
• Initial Date Manufacturer Received: 07/15/2019
• Initial Date FDA Received: 07/30/2019
• Supplement Dates Manufacturer Received: 08/07/2019; 07/23/2020
• Supplement Dates FDA Received: 08/16/2019; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 117