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

Model Number CARDIOHELP-I

Device Problem No Flow (2991)

Patient Problems Hemolytic Anemia (2279); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/19/2021

Event Type  malfunction  

Manufacturer Narrative

Log files of the affected cardiohelp for the reported event were retrieved and will be analysed by getinge engineering.A follow-up emdr will be submitted when additional information becomes available.

Event Description

The customer reported that the pump stopped during treatment.In the log files the error messages "arterial bubble detected" and "no flow signal" were noted.No harm to patient reported.Complaint id: (b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

It was reported that the pump stopped due to bubble alarm while unit was used for patient treatment.Then the message "no flow signal" was noted.A getinge service technician investigated the cardiohelp unit on (b)(6) 2021 and could not confirm any failure.The technician performed safety, calibration, and functionality checks to factory specifications.The log files for the reported event were analyzed by getinge life cycle engineering on (b)(6) 2021.It was noted that the pump was stopped by the user and not due to an intervention or alarm.Based on the investigation results the reported failure "pump stopped due to bubble alarm" could not be confirmed.The occurrence rate was calculated for the reported failure 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: CARDIOHELP
• 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: 12494352
• MDR Text Key: 272109362
• Report Number: 8010762-2021-00508
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K133598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CARDIOHELP-I
• Device Catalogue Number: 701048012
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1