MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE CLEARSIGHT MODULE

Model Number HEMCSM10

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/06/2021

Event Type  malfunction  

Manufacturer Narrative

The product will not be returned as the serial number was not secured for the product that was used.The diagnostic log files will be returned and reviewed.The findings from the log files will be submitted in a supplemental report when available.The device history record review could not be completed as the serial number is unknown.The udi number is unknown as the serial number is unknown.

Event Description

It was reported that there were inaccurate values with the clearsight module during patient use.The ci was not any higher than 1.9.There was no inappropriate patient treatment administered.There are no patient demographics available.There is no patient harm or injury.

Manufacturer Narrative

The diagnostic log review was completed and found that there were no inaccurate values that displayed on the hemosphere instrument.The log data did not contain a reference device, such as an a-line flotrac or a swan ganz catheter to compare the observed clearsight co ci measurements.Without a reference device, it is not possible to quantitively assess how co ci compares to a reference.However, reviewing the full hemodynamic profile of the case, using independent cardiovascular parameters, such as svv, ppv dp dt and blood pressure, it reveals that the patient was severely fluid depleted, with very low preload, very high svv and ppv significantly reduced cardiac contractility, very low dp/dt, and persistent hypotension throughout the case.The hemodynamic profile indicates the patient was in a hypovolemic condition, in which co ci must be low.There was very low pulse pressure which indicates low co.Additionally, the raw arterial pressure waveforms were reprocessed through the cotrek co algorithm, ev1000 monitor, and the resulting co ci data was compared to the apco co data of hsni monitor.The differences between the co's of the two algorithms are small and well within the expected range and both algorithms show similarly low co ci measurements, well below 2 l min m2.The data from the patient show no indication of inaccurate co or ci measurements.The data from the hsni device are consistent with the ev1000 device.The hemodynamic clinical data does not support the expectations in the event of co ci to be higher in the patient.The reported issue was not confirmed through review of the diagnostic log files.There is no evidence of inaccurate co measurements.The various analyses performed on several datasets show that the co measurements are accurate and well within the co acceptance criteria compared to a reference invasive co measurement.The analyses so far confirm that the hsni co measurements meet the co acceptance criteria.The clearsight co algorithm with apco performed as expected.H3 other text : product not received.

• Brand Name: HEMOSPHERE CLEARSIGHT MODULE
• Type of Device: CLEARSIGHT MODULE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 12368179
• MDR Text Key: 268224272
• Report Number: 2015691-2021-04856
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• PMA/PMN Number: K203687
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HEMCSM10
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1