MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG BE-HLS 7050#HLS SET ADVANCED 7.0; TUBING, PUMP, CARDIOPULMONARY BYPASS

Model Number BE-HLS 7050

Device Problem Complete Blockage (1094)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/16/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the customer: shortly after changing the hls set, there was visible thrombus in oxygenator, despite adequate levels of aptt and act.The platelets level was going down and p was raising.After 3 days during the platelets transfusion p very fast went high (over 120 mmhg).It was not possible to use this hls set any longer.Additional information: there were no negative consequences for the patient.(b)(4).

Manufacturer Narrative

Maquet medical systems,usa(importer)submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary ag kehler strasse 31, 76437 rastatt, germany.A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # e2018002.Importer- (b)(4).Contact person- (b)(6).During the rinsing of the hls oxygenator and the optical examination, strong clotting in the oxy was found.How and why these occlusions occurred during application in the clinic could not be traced.A supplemental medwatch will be submitted if additional information becomes available.

Event Description

Ref.: #(b)(4).

• Brand Name: BE-HLS 7050#HLS SET ADVANCED 7.0
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 8196127
• MDR Text Key: 131508252
• Report Number: 8010762-2018-00336
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 05/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• 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: 70124799
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention