MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE PRESSURE CABLE

Model Number HEMPSC100

Device Problems No Display/Image (1183); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 10/04/2019

Event Type  malfunction  

Manufacturer Narrative

The product will not be returned for evaluation; however, the diagnostic logs will be reviewed.Once the results are available a supplemental report will be submitted with the findings.The device service history record review is pending.Once the results are available a supplemental report will be submitted with the findings.The udi for the psc100 pressure cable is (b)(4).The mdr submission number for the hemisphere instrument will be submitted once available.

Event Description

It was reported that during patient monitoring with a hem1 instrument and psc100 pressure cable that the svr reading stopped being displayed.The arterial line was slightly damped.The hemodynamic readings were displayed normally.The co and other readings would drift down as the arterial line waveform was heavily damped.The crna countered this by flushing the line occasionally to open it up.The readings were displayed as expected, until the patient came off the pump unit.The svr readings stopped being displayed.The patient had calcified arteries.The slave cables were checked and verified to be properly connected.The cvp was displayed properly without interruption.They disconnected and reconnected the cvp slave cable and the cvp reading returned, but the svr reading did not return.The psc100 pressure cable was disconnected and reconnected and re-zeroed.The co and related readings were lost as the arterial line was still damped.The crna placed a femoral arterial line and reconnected the flotrac to the femoral line.The co readings returned, but the svr did not display.There was no patient harm or injury reported.There was no report of inappropriate patient treatment administered.

Manufacturer Narrative

Product was not returned for evaluation.However, diagnostic logs were reviewed and revealed the following: the fault ¿check arterial waveform¿ message triggers the cvp source and averaging state.Because these cvp selections do not get set back after the fault, the svr is not displayed.The cvp, however, is still available.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 mdr submission number for the hem1 instrument involved 2015691-2019-03975.

Manufacturer Narrative

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

• Brand Name: HEMOSPHERE PRESSURE CABLE
• Type of Device: HEMOSPHERE PRESSURE CABLE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 9241817
• MDR Text Key: 194291770
• Report Number: 2015691-2019-03976
• 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,Followup
• Report Date: 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HEMPSC100
• Device Catalogue Number: HEMPSC100
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1