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

Catalog Number 701048012

Device Problems Failure to Read Input Signal (1581); Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591)

Patient Problem Low Cardiac Output (2501)

Event Date 06/06/2017

Event Type  Death  

Manufacturer Narrative

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

Event Description

(b)(4).During a patient treatment no flow on cardiohelp occurred and bubble detector alarm was evident.Staff attempted to clear the alarm, but they could not use the global override function, screen appeared frozen.Patient transferred to hand crank.During transfer, patient suffered loss of cardiac output.The suspect cardiohelp was replaced and flow established.All appropriate checks carried out.It was reported that the patient is stable when on ecmo.

Manufacturer Narrative

On 07/06/2017: it was reported that the patient was stable after the reported incident on day 25 (and a similar brief incident on day 9) of the ecls run.It was also reported that the patient¿s lungs never showed signs of recovery and she died after 52 days on ecls.

Event Description

(b)(4).

Manufacturer Narrative

Since the whole device has been sent to life cycle engineering (lce), it has not been repaired by a maquet field service technician.Therefore a service report does not exist.Result of investigation report lce 3355 and log-files analysis: since the device ran on emergency mode, the screen was locked.Therefore the customer could not deactivate interventions or to activate the "global override" mode.Before starting the emergency mode the arterial bubble sensor has been removed from the device.According to the logfiles of the cardiohelp the described behavior could be reconstructed.No device-defect could be proven.The most probable root cause is a user error.

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: 6637009
• MDR Text Key: 77439335
• Report Number: 8010762-2017-00192
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: EI
• 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,Followup
• Report Date: 10/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 701048012
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 07/06/2017
• Date Device Manufactured: 02/01/2011
• 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): Life Threatening
• Patient Age: 44 YR