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

Model Number CARDIOHELP-I

Device Problem No Flow (2991)

Patient Problem Death (1802)

Event Date 10/30/2018

Event Type  Death  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).

Event Description

According to the hospital: during an intervention for a cardiac arrest at 06.30 pm, the ecmo is primed and put in place without problem.The patient was connected.But during use, the medical staff observed a coherent rpm but with a flow at 0 l/min.The medical staff performed an external cardiac massage but the patient died.(b)(4).

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).A service technician visited the hospital on 2019-01-09 and checked according to service (b)(4) the device.The technician could not find any failure at the device.The hospital informed us, that the patient was in a bad condition and they used the cardiohelp as a last solution.The event they complaint about, no flow, was caused according to the log-file analysis by a safety measure, the back flow prevention.As there was no malfunction no further action is needed.

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: 8196122
• MDR Text Key: 131415102
• Report Number: 8010762-2018-00337
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K102726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CARDIOHELP-I
• Device Catalogue Number: 70104.8012
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2012
• 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