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

Catalog Number 7010048012

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 04/13/2017

Event Type  Death  

Manufacturer Narrative

(b)(4).The device function will be checked after it is releases from sentara risk management a supplemental medwatch will be submitted after new information has been received.

Event Description

(b)(4).It was reported that during a patient treatment the patient died.

Manufacturer Narrative

The device was sent into the depot for a repair unrelated to this incident.Cardio help repair, complete pm ,full functional, calibration and safety tests as per service manual.Unit passed all tests.The cardio help was tested with a test circuit for 4 days at 4000 rpm with lpm set at 4.00.Unit ran 24 hours for 4 days wit now failures.Per the local cardiothoracic account manager the device was not being blamed for the patient incident.As stated by the customer, the affected hardware (hls-set/hls-module, used cannula) is no longer available.Therefore no further investigation possible.Customer suspected as most probable root cause "issue related to cannula positioning and or possible occlusion of some kind".

Event Description

(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: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; 4972229321
• MDR Report Key: 6547218
• MDR Text Key: 74506944
• Report Number: 8010762-2017-00136
• 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: consumer,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/17/2017,08/04/2017

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: 7010048012
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/04/2017
• Event Location: Hospital
• Date Report to Manufacturer: 04/17/2017
• Initial Date Manufacturer Received: 04/14/2017
• Initial Date FDA Received: 05/05/2017
• Supplement Dates Manufacturer Received: 04/14/2017
• Supplement Dates FDA Received: 08/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• 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