MAUDE Adverse Event Report: HEMCSM10; 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 07/29/2021

Event Type  malfunction  

Manufacturer Narrative

The product has not been returned for evaluation.When it arrives and the product evaluation has been completed, a supplemental report will be submitted.The device history record review was not completed but will be provided after it has been finished.

Event Description

It was reported that the hemcsm10 was used with an or patient and a low ci value was displayed but was confirmed higher due to a previous cardiac work up before surgery.There was no inappropriate treatment based on the numbers as the physician believed the numbers were inaccurate.The only demographic received was that the patient was (b)(6) years old.The rep believes the issue has been isolated to the hemcsm10.There will be no product return as logs were sent in to be evaluated.

Manufacturer Narrative

The device history record review was completed and all inspections passed with no non-comformances.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 aline 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 dpdt 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 cos 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.No difference in the different device algorithms was observed.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.

• Brand Name: HEMCSM10
• Type of Device: CLEARSIGHT MODULE
• MDR Report Key: 12416636
• MDR Text Key: 270667527
• Report Number: 2015691-2021-04827
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 00690103197006
• UDI-Public: (01)00690103197006(11)201226(2
• Combination Product (y/n): N
• PMA/PMN Number: K142749
• 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: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HEMCSM10
• Device Catalogue Number: HEM1
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/26/2020
• 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
• Patient Age: 80 YR