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

Model Number MCP00703309#RPM 20-320 SINGLE ROLLER PUMP

Device Problem Failure to Pump (1502)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that the error message "head error" was displayed on the hl20 pump after startup of the device.No harm to any person was reported.Complaint id# (b)(4).

Manufacturer Narrative

The investigation is ongoing.As soon as new information becomes available, a follow up medwatch will be submitted.

Event Description

Complaint id# (b)(4).

Manufacturer Narrative

This is a follow up report to complaint (b)(4) which was reported under mfr#, which is a doublicate entry to complaint #(b)(4), final reported under mfr#8010762-2021-00647 on 2023-02-01.

• 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
• Manufacturer (Section G): JULIA KAPFENBERGER; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 16348543
• MDR Text Key: 309383281
• Report Number: 8010762-2023-00077
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K943803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCP00703309#RPM 20-320 SINGLE ROLLER PUMP
• Device Catalogue Number: 70102.7652
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/03/2014
• Is the Device Single Use?: No
• Type of Device Usage: A
• Patient Sequence Number: 1