MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HLS SET ADVANCED 5.0 WITH BIOLINE COATING; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BEQ-HLS 5050 USA#HLS SET ADVANCED 5.0

Device Problem Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/31/2020

Event Type  malfunction  

Event Description

It was stated that the oxygenator clotted off quickly.The customer grabbed a second hls and switched it out.(b)(4).

Manufacturer Narrative

Results of laboratory investigation: the oxygenator had to be rinsed out several times to wash out all clots.After connecting the hls set to a cardiohelp no values for the arterial and delta pressure were displayed.Further inspection revealed yellow discolored arterial and internal pressure sensor.No leakages could be observed.Thus the reported failure "oxygenator clotted" could be confirmed.According to the risk assessment (hls set advanced 5.0 / hls set advanced 7.0, dms # 1468452, v22) following causes could lead to clotting: -air remains in or enters the circuit -hemostasis -too low anticoagulation -too low at level, effect of heparin is too limited -protamine sulfate enters the hls set -administration of substitution of congealable substance such as plateles the occurrence rate regarding the above complaint is below the acceptance rate.Thus, no remedial action required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.

Event Description

Complaint id: (b)(6).

• Brand Name: HLS SET ADVANCED 5.0 WITH BIOLINE COATING
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 9666706
• MDR Text Key: 204362431
• Report Number: 8010762-2020-00046
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K112360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 04/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BEQ-HLS 5050 USA#HLS SET ADVANCED 5.0
• Device Catalogue Number: 701052797
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Date Manufacturer Received: 04/21/2020
• Patient Sequence Number: 1