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

Model Number HL 20

Device Problem Pumping Problem (3016)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/07/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During the pre-surgery inspection, the medical staff found that the double-head pump of the extracorporeal circulation machine reported an error message in cpl mode: stop--.Complaint #(b)(4).

Event Description

Complaint (b)(4).

Manufacturer Narrative

During the pre-surgery inspection, the medical staff found that the double-head pump of the extracorporeal circulation machine reported an error message in cpl mode: stop.The field service technician (fst) was sent for further investigation.According to service order dated on 2020-12-23 it was found that a data transmission pin was bent on the odu connector at the base of the double-head pump.Re-fixing the data transmission pin, the failure and alarm information are eliminated, and the test operation returns to normal.The device is working properly.Thus the reported failure could be confirmed.The most probable root cause of the reported failure could be determined as a bent pin on the odu connector.The review of the non-conformities during the period of 2015-06-01 to 2020-12-17 does not show any non-conformity in regard to the reported product and failure.There is no indication that manufacturing issues occurred during this time, thus production related influences can be excluded.The reported failure did not happen during 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.

• Brand Name: HEART LUNG MACHINE
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 11051760
• MDR Text Key: 227111678
• Report Number: 8010762-2020-00446
• 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: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• 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: 701043262
• Date Manufacturer Received: 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1