MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HLM TUBING SET W/BIOLINE COATING; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BE-HLS 7050#HLS SET ADVANCED 7.0

Device Problem No Flow (2991)

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

Event Date 04/09/2020

Event Type  malfunction  

Event Description

Complaint number: (b)(4).The failure is delta p rise with constant drop in flow over the period.No harm to patient reported.

Manufacturer Narrative

The laboratory investigation was performed on 2020-06-05.As stated in the investigation report clots could be found inside the oxygenator.The arterial pressure could not be displayed.In addition the adhesive membrane on the sensors shows a yellowish discoloration in all sensors.Thus the reported failure could be confirmed.The most probable root cause are clots in the oxygenator.According to the risk assessment (hls set advanced 5.0 / hls set advanced 7.0, dms # (b)(4), v22) following causes could lead to coagulation: -de-airing luer lock connection too loose; -air remains in or enters the circuit ; -hemostasis; -air or blood remains in luer lock access port; -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; -(consumption) coagulopathy; -thrombocytopenia.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.The occurrence rate was calculated for the reported issue and it was determined that this is not a systemic issue.Therefore, no remedial action is required.

Event Description

Complaint id: (b)(4).

• Brand Name: HLM TUBING SET W/BIOLINE COATING
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 9994549
• MDR Text Key: 200700835
• Report Number: 8010762-2020-00133
• 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,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 06/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BE-HLS 7050#HLS SET ADVANCED 7.0
• Device Catalogue Number: 70104.7753
• Device Lot Number: 70133987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2020
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 06/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other