MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE HEMPSC100; HEMOSPHERE PRESSURE CABLE

Model Number HEMPSC100

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/20/2020

Event Type  malfunction  

Manufacturer Narrative

One hemosphere pressure cable was received for product evaluation.The system verification test was performed.The pressure cable zeroed successfully with no error messages noted.The mean arterial pressure values displayed on the screen and started at 96.Over a ten minute span the values rose to 105.They held steady at 105.The map value limits are between 105-125.An internal inspection was performed and there was contamination found on the flex of the front connector assembly.There was no visible contamination found on the internal boards or internal housing.Once the connector assembly was replaced then the test was re-run and the values remained steady and within appropriate parameters.The root cause was found to be liquid ingress.This issue was identified during the product evaluation process.The inaccurate values did not occur in a clinical setting.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.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.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to the complaint.The device history record review was completed and all manufacturing inspections passed with no non-conformances.Udi information (b)(4).

Event Description

It was reported that the hemosphere pressure cable will zero appropriately for flotrac monitoring and then work for a few minutes, then it will stop.Only re-zeroing each time will enable the values to be obtained.This occurred several times during patient monitoring.The edwards representative was present and assisted with the troubleshooting.There was no patient injury.There was no inappropriate patient treatment reported.

Manufacturer Narrative

Additional testing and analysis was performed on the pressure cable by edwards r&d engineers.There was white residue observed at the front connector flex cable.The front connector assembly was removed from the unit and an electrical isolation test was performed.A 14.2 ohm resistance was found between pins 3 and 4 which corresponds to sig- and sig+ lines.This is consistent with abnormal behavior confirmed by the system verification testing.Further disassembly showed more evidence of white residue at the flex cable of the front connector, button gasket, button and led/button pcba.It was difficult to visually detect white residue at other locations due to the white plastic and lack of contrast.Samples of the white residue were taken and analyzed using sem/eds analysis.There were traces of sodium and chlorine detected.There is no solid evidence to support any theories of the ingress pathway.The first product evaluation cause of liquid ingress is valid.The facility will be contacted to be informed of the evaluation results and a reminder of the ifu instructions regarding cleaning procedure and to avoid contact with liquid.

• Brand Name: HEMOSPHERE HEMPSC100
• Type of Device: HEMOSPHERE PRESSURE CABLE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 10722739
• MDR Text Key: 213186252
• Report Number: 2015691-2020-14083
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• PMA/PMN Number: K180881
• 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: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HEMPSC100
• Device Catalogue Number: HEMPSC100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2020
• Date Manufacturer Received: 11/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FLOTRAC