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 Problems Backflow (1064); No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2019

Event Type  malfunction  

Manufacturer Narrative

A follow up medwatch will be submitted when additional information becomes available.

Event Description

A patient was putted on ecmo.The system was started and the treatment went on for about 20 minutes.Good flow, and everything was fine.After about 20 mins the rpms on the cardiohelp was putted to zero (stopped the flow) due to a shunt being installed in the patients leg.When the perfusionist was going to start the flow again (going up in rpms) the cardiohelp did not show any flow, only rps.The perfusionist tried again to zero the rpms and go up again with no success.The perfusionist can now see a backflow (minus flow) and believes that in this stage the only right thing to do is to hand crank, which they do.(b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

Upon investigation the failure was traced to the hls set, not the cardiohelp.Thus the product details were updated.The hls module was investigated in the laboratory on 2020-01-31.Results: during visual inspection foreign body was found in the pump housing.The most likely guide wire from a catheter was wrapped around the rotor of the pump and blocked it.The guide wire must have entered the rotor pump at the customer's site through the blood inlet connector.Since the pump could not rotate at the customer, no flow was produced and no flow values were shown on the display of the cardiohelp.Thus the root cause is a catheter guide wire blocking the pump rotor.The failure could be confirmed but it was no product related malfunction as the guide wire must have entered the oxygenator at the customer's site, most likely during the shunt installing.The occurrence rate 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.

• 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: 9446123
• MDR Text Key: 199312109
• Report Number: 8010762-2019-00387
• 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: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Initial Date Manufacturer Received: 12/05/2019
• Initial Date FDA Received: 12/10/2019
• Supplement Dates Manufacturer Received: 01/31/2020
• Supplement Dates FDA Received: 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1