MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH BEQ-HLS 7050 HLS SET ADVANCED 7.0; TUBING, PUMP, CARDIOPULMONARY BYPASS

Model Number BEQ-HLS 7050

Device Problem Defective Component (2292)

Patient Problem Death (1802)

Event Date 12/15/2018

Event Type  Death  

Manufacturer Narrative

(b)(4).Lab investigation at the factory: a beq-015703112#hls module advanced adult was delivered as a complaint sample.An optical examination and a tightness test according to lv 201 (blood side) were carried out.The results of the tests were documented in writing and pictures and filed in the complaints folder.The optical examination of the oxygenator did not reveal any detectable defects.While cleaning and flushing the gas side, a clot was flushed out at the gas outlet.In the subsequent leak test according to lv 201, a leak was found on the pressure sensor located on the blood inlet channel.The adhesive connection between the pressure sensor and blood inlet channel is not ok.In order to perform another leak test to check the tightness from the gas to the blood side of the oxygenator, the leaky adhesive connection from the pressure sensor to the blood inlet channel had to be sealed.After the sealing of this leaky spot a leak test according to lv 201 was carried out again and a leakage from the blood side to the gas side was detected.The mfr report # for this event is 8010762-2019-00006.

Event Description

According to the customer: customer put a patient on cardiohelp on (b)(6) 2018, and noted blood from the exhaust port on the oxygenator.The oxygenator failed at hour 24.Patient co2 remained normal-co2 on oxygenator in the 90s venous and arterial.Circuit was changed out and patient only off pump for 4 minutes.They also had impella running at 2l.Patient became non responsive at midnight on (b)(6) 2018.(b)(4).On march 5, 2019: the factory was informed that after requesting the outcome of the patient, the complaint initiator forwarded information that the patient expired.This information was sent to the ssu on march 13, 2019 which necessitated the filing of a importer e-mdr- this report.The mfg report # for this event is # 8010762-2019-00006.

• Brand Name: BEQ-HLS 7050 HLS SET ADVANCED 7.0
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• 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: 8420198
• MDR Text Key: 138795002
• Report Number: 3008355164-2019-00004
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BEQ-HLS 7050
• Device Catalogue Number: 70152794
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/13/2019
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death