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

Catalog Number 701048012

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 10/15/2017

Event Type  Death  

Manufacturer Narrative

A field service technician was sent to investigate the issue.He downloaded the log files and checked the device.He did not find any failures at the device.According to service order (b)(4) the unit passed all checks and was cleared for clinical use.(b)(4).A supplemental medwatch will be submitted after new information has been received.Ref exemption- (b)(4).

Event Description

Customer reported that the unit was alarming negative pressure during a patient case.Could not get alarming to stop.Critical patient deceased.Internal reference: (b)(4).

Manufacturer Narrative

To get a root cause , a clinical assessment has been prepared by a clinical application manager.Conclusion: sufficient anticoagulation control (act, ptt) is not supported by the questionnaire.Flow calibration of the flow measurement was not done.No sensor intervention was enabled.Air entered the perfusion system.The root cause of the incident is unknown by clinical side because of insufficient information.Thus the failure could not be confirmed.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time.Since the device had no failure no corrective action is needed.In addition at this time it cannot be concluded that it is a systemic error.No corrective action is needed.

Event Description

(b)(4).

• Brand Name: CARDIOHELP-I
• 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: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; 4972229321
• MDR Report Key: 7005671
• MDR Text Key: 91203673
• Report Number: 8010762-2017-00357
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/17/2017,11/14/2017

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 701048012
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/14/2017
• Event Location: Hospital
• Date Report to Manufacturer: 10/17/2017
• Initial Date Manufacturer Received: 10/17/2017
• Initial Date FDA Received: 11/07/2017
• Supplement Dates Manufacturer Received: 10/17/2017
• Supplement Dates FDA Received: 11/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2016
• 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