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

Catalog Number 701072780

Device Problem Pumping Stopped (1503)

Patient Problem Death (1802)

Event Date 05/22/2019

Event Type  Death  

Event Description

The customer stated that during support on cardiohelp the venous bubble sensor alarm activated (low level alarm was active) due to a bubble in the venous line.At the same time the venous bubble sensor activated, the arterial bubble sensor activated and stopped the pump (intervention was active).The lines were clamped and the bubble in the venous line was removed.The arterial line was inspected, but no bubbles were observed.Cardiohelp was restarted once the lines were confirmed to be free of air.Also, the customer stated that the arterial sensor was not jarred, bumped, or jostled in the process of debubbling.The customer stated that there seemed to be no reason to the arterial bubble to activate at the same time as the venous bubble sensor, yet for no apparent reason.The customer stated that the patient expired, but not due to this situation as the support was restarted after confirming there were no bubbles.Ot # (b)(4).

Manufacturer Narrative

Due to the information by the customer two cardiohelps were involed with the serial#(b)(4) and serial# (b)(4).The customer did not know what console exhibited the event.As the ssu is unsure which cardiohelp serial number is concerned both serial# were checked by a technician with the following results: cardiohelp serial#(b)(4): according to the service order report 43130746 the technician did a system restore, complete pm, calibration, full functional tests and safety tests as per the service manual.The unit passed all tests.This work was performed on 2019-09-24/26.Cardiohelp serial#(b)(4): according to the summary report 43148309 the technician did a system restore, complete pm, calibration, full functional tests and safety tests as per the service manual.The unit passed all tests.This work was performed on 2019-10-15/16.Thus the failure could not be confirmed.Thus a most probable root cause could not be determined.Based on the information available at this time the cause of this failure was determined to not be attributed to a device related malfunction.A medical review (dated 2019-10-23) was requested with the following conclusion: "there is evidence that the hardware of the cardiohelp-i was acting as specified (no hardware error).There is evidence that the user act during the alarm situation as the manufacturer expected (no use error).Why or how air bubbles or particles get into the hls-set advanced is unknown (possible use error).It is unknown that the event was during start of the perfusion and imperfect mixing of blood and priming was leading to the pump stop (possible use error).It is unknown that other devices disturbed the cardiohelp-i during the event (possible use error or technical error).It is unknown that a software error was leading to the event (possible software error).It is not possible to define the final root cause of the event, because of lack of information.The ocurrance rate related to the reported issue is currently being monitored as part of maquet cardiopumonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.

Event Description

Complaintnumber: (b)(4).

• Brand Name: CARDIOHELP-I, US-VERSION
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 8912912
• MDR Text Key: 154958310
• Report Number: 3008355164-2019-00011
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 701072780
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/01/2019
• Distributor Facility Aware Date: 10/15/2019
• Event Location: Hospital
• Date Report to Manufacturer: 11/01/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/20/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death