MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH CARDIOHELP-I; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number CARDIOHELP-I

Device Problems Detachment of Device or Device Component (2907); No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/20/2020

Event Type  malfunction  

Manufacturer Narrative

A follow-up emdr will be submitted when additional information becomes available.

Event Description

Failure description from customer: so bed 10 sat's have been down all morning.Came out of room to discuss with dr.(b)(6) about intubating patient.We were outside of his room and the cardio-help pump started alarming.I ran in the room and the screen was reading air bubble detected.The machine was shut down.I clamped off and tried to reset the alarm.(with me clamping off zero flow did not come on) i turned down flow to zero and back up.Unclamping and no flow.I tried two more times to reset alarm and nothing.At the same time i was resetting alarm (b)(6) came in.He also tried to reset it.It didn't work so we took oxygenator off pump and started hand cranking.We hand cranked patient until vitals were better.We tried to place back on pump and it came up an error cassette something.We put back on hand crank.We shut down the power to the pump to reset it.Turned it back on and everything worked.(b)(4).

Event Description

Complain id:(b)(4).

Manufacturer Narrative

It was reported that the customer was unable to clear the bubble alarm till the cardiohelp was restarted.Further a venous probe issue was reported.A picture showing the issue was provided.A getinge field service technician was sent for investigation on 2020-12-23, he could not reproduce the failure.He performed a full maintenance and all tests were passed successfully.According to the technician the venous probe case was reconnected by the customer before the maintenance.The review of the complaint was performed by getinge life cycle engineering on 2021-02-22.It was reported that on receipt of the bubble alarm, the circuit was clamped and the alarm was reset.No information if the circuit was checked for air or if air was removed.Further, the flow was set to zero after clamping.This procedure could have been caused the error "wrong target lpm/rpm" leading to a pump stop.Further it was reported that after that the hls module was disconnected and after use of the emergency drive it was reattached to the cardiohelp.Multiple error messages were reported most probable the error "wrong target lpm/rpm" followed by "pump disposable error - stop" was displayed.This error is triggered if there is a deviation between set target lpm/rpm and actual lpm/rpm e.G.If the disposable is disconnected without putting the lpm/rpm to zero.Setting target lpm/rpm to zero and then again to the desired values clears this error.In this case the whole cardiohelp unit was restarted.(refer instruction for use cardiohelp system v1.15, chapter 9.4 technical alarms) based on the results the reported failure "bubble unable to clear" could not be confirmed.The most probable root cause could be a handling error (e.G.Inexperienced user).The sales and service unit was advised to make the customer aware of the mentioned instruction for use.Based on the results the reported failure ¿venous probe issue¿ could be confirmed as the provided picture showed the open venous probe case.The most probable root cause is a mechanical impact/ hit or wear of the venous probe case (in use since 2014).The occurrence rate was calculated for the reported failure and it was determined that this is not a systemic issue.Therefore, no remedial action is required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿ s trending program and additional investigations or corrections will be implemented in case of adverse trending.

• Brand Name: CARDIOHELP-I
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 11100008
• MDR Text Key: 224844769
• Report Number: 8010762-2020-00463
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K133598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 03/08/2021

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 Model Number: CARDIOHELP-I
• Device Catalogue Number: 701048012
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/29/2020
• Initial Date FDA Received: 12/31/2020
• Supplement Dates Manufacturer Received: 02/22/2021
• Supplement Dates FDA Received: 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1