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 08/23/2020

Event Type  malfunction  

Manufacturer Narrative

A "venous bubble sensor defective" error during treatment was reported.As informed by the service and sales unit on 2020-09-09 the venous bubble sensor has to be replaced.After decision by customer a new venous bubble sensor will be ordered and replaced.A similar failure was already investigated by life cycle engineering (lce) with the following result: as stated in the investigation report the malfunction could be confirmed.The venous bubble sensor was connected to a reference cardiohelp.During boot up the error 0000a025 bubble2 sensor is defective was displayed.The sensor was not recognized by the cardiohelp.The affected sensor was sent to the supplier sonotec gmbh on 2020-02-21 (rma20-101072) to determine the root cause.Sonotec gmbh confirmed the failure.According to their investigation the sensor is electrically damaged.Following possible root causes were determined: damaged cable due to mechanical tension.Damage due to overvoltage or esd (electrostatic discharge).Based on this the reported failure ""venous bubble sensor defective" could be confirmed.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

Reporting decision re-evaluated: a "venous bubble sensor defective" error was reported.Issue occurred during patient treatment.No indication of actual or potential for harm or death.Complaint number: (b)(4).

• 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: 12341554
• MDR Text Key: 267237799
• Report Number: 8010762-2021-00459
• 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,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/19/2021

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: 70107.2780
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2021
• Initial Date FDA Received: 08/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2018
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 51 YR