MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG BE-HLS 7050#HLS SET ADVANCED; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number BE-HLS 7050

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Death (1802); Respiratory Distress (2045); Vascular System (Circulation), Impaired (2572)

Event Date 07/06/2016

Event Type  Death  

Manufacturer Narrative

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

Event Description

Customer reported that "hls module when coupling the module to the cardiohelp there was not circulation.At the time of priming, the device stops automatically and there was no recirculation of water.Take note that priming was done using a demo hls module.The device was not replaced during treatment.Patient died due to cardio respiratory problems.(b)(4).

Manufacturer Narrative

The product (hls module advanced 7.0) has been delivered to maquet for investigation.It has been cleaned and during visual inspection it has been noticed that the pump still jammed.The sample has then been connected to the cardiohelp.During set up, the pressure went down and the pump was no longer jammed.The test could be performed according to specification.No abnormalities were found during the test run.Thus the failure could be confirmed.The exact root cause could not be determined.The hls set was replaced before use on patient.The first set could not be installed from the beginning.The patient died due to cardiorespiratory problems not due to product malfunction.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.

Event Description

(b)(4).

• Brand Name: BE-HLS 7050#HLS SET ADVANCED
• 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: 5997453
• MDR Text Key: 56395683
• Report Number: 8010762-2016-00601
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: PE
• PMA/PMN Number: K943803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BE-HLS 7050
• Device Catalogue Number: 701047753
• Device Lot Number: 70099753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death