MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HEART LUNG MACHINE HL20; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number HL 20

Device Problem Pumping Problem (3016)

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

Event Date 10/06/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Suring surgery the roller pump in art mode was ringing intermediately (around 15 times per minutes) with the blinking error message "stop --" and sometimes the perfusionnist could read "stop pr1".Reference number: (b)(4).

Manufacturer Narrative

Device manufactured on 2020-03-19.The device history record (dhr) of the hcu40 (material: 70104.3266, serial: (b)(6)) for which a customer complaint was received, was reviewed on 2020-12-01.The dhr does not show any abnormality or issue that is related or can have led to the customer complaint.According to the support case#(b)(4) the field service technician performed as follows: the getinge technical service suggested to replace the complete twin pump house assy mat#70105.2345 because it was assumed that a pump/encoder is defective.After replacement of the twin pump hose assy the issue was resolved.The reported failure was error message: "stop--" and "stop pr1".The most probable root cause could be determined to a defective pump/encoder.Which was resolved by replacing the complet pump house assy.The reported failure "error message: "stop--" and "stop pr1"" could be confirmed.The reported failure "error message: "stop--" and "stop pr1" did occur durin patient treatment.The hl20 in question was responsible for this complaint/event.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.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

Reference number: (b)(4).

• Brand Name: HEART LUNG MACHINE HL20
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 10688858
• MDR Text Key: 211682179
• Report Number: 8010762-2020-00345
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K943803
• 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: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HL 20
• Device Catalogue Number: 70102.8581
• Date Manufacturer Received: 10/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1