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

Model Number CARDIOHELP-I

Device Problem Communication or Transmission Problem (2896)

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

Event Date 11/08/2021

Event Type  malfunction  

Event Description

A flow/bubble sensor failure during treatment was reported.The information received, that the cardiohelp was changed.No indication of actual or potential for harm or death was reported.Complaint number: (b)(4).

Manufacturer Narrative

A follow up will be submitted when additional information become available.A getinge service technician will investigate the cardiohelp.

Event Description

Complaintnumber: (b)(4).

Manufacturer Narrative

A flow/bubble sensor failure was reported during treatment.A getinge field service technician was sent for investigation on 2021-11-15.He could not confirm the failure.According to the technician the user reported the bubble alarms came fairly quickly at first, then slowly stopped appearing.The log files of the cardiohelp shows that the unit had multiple arterial bubble alarms that were cleared by the user.No unexpected bubble alarms could be confirmed.The unit was tested an put back in use.An exact root cause could not be identified.However, with reference to the current risk file the following possible causes could be linked to the reported failure: bubble intervention not working wrong information.Influence due to other ultrasonic devices (e.G.Flow sensor); environmental influences (atmospheric pressure, temperature, humidity, emi, overvoltage.Based on the investigation results, the reported failure "flow/bubble sensor failure" could not be confirmed.Furthermore, it could be confirmed, that the cardiohelp worked as per factory specifications.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: 12787149
• MDR Text Key: 280584360
• Report Number: 8010762-2021-00598
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/02/2021

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: CARDIOHELP-I
• Device Catalogue Number: 701048012
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2021
• Initial Date FDA Received: 11/10/2021
• Supplement Dates Manufacturer Received: 11/15/2021
• Supplement Dates FDA Received: 12/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2012
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1