MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG CARDIOHELP SYSTEM; CARDIOPULMONARY SUPPORT SYSTEM

Model Number 70104.8012

Device Problems Device Displays Incorrect Message (2591); No Flow (2991)

Patient Problems Death (1802); Blood Loss (2597)

Event Date 01/30/2015

Event Type  Death  

Event Description

It was reported that during pt ecmo treatment, a zero flow mode on the cardiohelp-i was activated due to a high priority alarm appearing for no obvious reason.The pt's sternum was still open and the skin closed.The doctor opened the skin and a pool of blood exited.The pt's heart was massaged and a perfusionist was notified.The flow was re-established and the pt was transported to the operating room.The pt expired a few days later.Ecmo - extra corporeal membrane oxygenation.Ref.: (b)(4).

Manufacturer Narrative

(b)(4) has not investigated the unit.The product failure investigation, analysis and resolution for the device described in this report will be provided by maquet cardiopulmonary ag.A supplemental medwatch will be submitted when additional information becomes available.

Manufacturer Narrative

According to the analysis of one of maquet's therapy application managers the time when air entered in the perfusion system was signalled acoustically and visually as well as triggered the zero flow mode.The venous bubble sensor was reset 26:11 minutes later for unknown reason.The read-out of the offline-data of the cardiohelp-i represented a behavior as specified.But the cause of the time interval of 26:11 minutes for reset of the venous bubble sensor and the air in the perfusion system is unknown by clinical side due to insufficient information.Therefore the cardiohelp-i worked as expected when the zero flow mode was activated due to the bubble detection.Therefore the claimed failure could not be confirmed.

Event Description

(b)(4).

• Brand Name: CARDIOHELP SYSTEM
• Type of Device: CARDIOPULMONARY SUPPORT SYSTEM
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer Contact: michael campbell ; kehler strasse 31; rastatt 76437 ; GM 76437 ; 2229321132
• MDR Report Key: 4562195
• MDR Text Key: 5547198
• Report Number: 8010762-2015-00067
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K102726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Distributor,distributor,forei
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/02/2015

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: Health Professional
• Device Model Number: 70104.8012
• Device Catalogue Number: 70104.8012#CARDIOHE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2015
• Initial Date FDA Received: 02/27/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2015
• 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 Outcome(s): Death; Required Intervention