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 No Known Impact Or Consequence To Patient (2692)

Event Date 12/15/2018

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 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).

Manufacturer Narrative

(b)(4) (importer) submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary ag kehler strasse 31, 76437 rastatt, germany.Reference exemption # e2018002.Importer: (b)(4).After requesting about the patient outcome, the complaint initiator forwarded the information that the patient expired.Lab investigation: a (b)(4) # 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 clott 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.

Event Description

Ref.: #(b)(4).Customer ref.: (b)(4).

• 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
• MDR Report Key: 8240215
• MDR Text Key: 132962151
• Report Number: 8010762-2019-00006
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• PMA/PMN Number: K080592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: BEQ-HLS 7050
• Device Catalogue Number: 70152794
• Device Lot Number: 70115420
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/13/2019
• Event Location: Hospital
• Date Manufacturer Received: 03/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention