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

Catalog Number 701048012

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Death (1802)

Event Date 04/23/2018

Event Type  Death  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).(b)(6).

Event Description

A patient expired while being on cardiohelp for more than a month's time.Air was introduced into the system, but it was believed to be caused by the patient and not the cardiohelp.(b)(4).

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).Service order# (b)(4), dated: 2018-05-25 was received on 2019-01-22.According to service order# (b)(4) the technician performed as follows: completed pm with full calibration on cardiohelp unit serial no.(b)(4).Unit passed all functional and safety tests per factory specifications.Returned to customer and cleared for clinical use.Thus the failure could not be confirmed.According to the e-mail from (b)(6) from 2019-01-21: he submitted the complaint in trackwise with the description of the event.The chief perfusionist ((b)(6)) gave him information regarding the issue.The chief perfusionist did not believe that air entered the system through the cardiohelp as it is a closed system and was not manipulated at the time of entry.It is believed to have entered the patient somewhere else, but not specified.The air was a contributing factor in the patient's death.

Event Description

Internal reference- (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: 7540742
• MDR Text Key: 109139500
• Report Number: 8010762-2018-00180
• 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: 04/26/2018,01/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 701048012
• Device Lot Number: 90421463
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/23/2019
• Event Location: Hospital
• Date Report to Manufacturer: 04/26/2018
• Date Manufacturer Received: 04/26/2018
• 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