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

Device Problem Device Stops Intermittently (1599)

Patient Problem Death (1802)

Event Type  Death  

Event Description

(b)(4).

Manufacturer Narrative

Maquet cardiopulmonary (b)(4) has not investigated the unit.Log files were reviewed from the unit which did not confirm a malfunction of the device.The product failure investigation, analysis and resolution for the device described in this report will be provided by maquet cardiopulmonary (b)(4).A supplemental medwatch will be submitted when add'l info becomes available.(b)(4).

Manufacturer Narrative

A maquet technician investigated the device.Performed full functional and safety tests.Even a simulated bubble test was performed 10 times and the cardiohelp responded correctly each time.Final conclusion is "no fault with the device".The service log files of the device was also retrieved and sent to complaint department for evaluation.O a technical evaluation reported that the rpm pump did not turn/rotate during the time period of 09:07 and 10:48 on (b)(6) 2015, however, no obvious fault could be found for the cardiohelp device itself.O a clinical complaint analysis (received 25.02.2015) was also performed which observed that certain initial set operational functions were not performed during set up on (b)(6) 2015.It was also observed that there were certain interventions made during patient use.However, the final outcome of the analysis concluded that no defect could be determined based on the information provided from the log files.This first follow-up report will also serve as a final report for this complaint.

Event Description

(b)(4).The initial medwatch for this complaint was submitted on paper under mfr# 8010762-2015-00068 and (b)(4).

• Brand Name: CARDIOHELP SYSTEM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): BERND RAKOW; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; GM
• Manufacturer Contact: michael campbell ; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt 76437 ; GM 76437 ; 4972229321
• MDR Report Key: 4580098
• MDR Text Key: 17215605
• Report Number: 8010762-2015-00068
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K102726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,company representati
• Type of Report: Initial,Followup

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?: No
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/09/2015
• Initial Date FDA Received: 03/04/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1