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 Type  malfunction  

Manufacturer Narrative

A getinge service technician investigated the unit on 2021-05-24 and 2021-06-01 and could not reproduce the failure.The technician performed safety, calibration, and functionality checks to factory specifications.For further analysis the log files for the reported event were analyzed by getinge life cycle engineering on 2021-08-02.It could be confirmed that the error message "ven.Bubble sensor defective" was logged several times for the date of event.The review of the non-conformities has been performed on 2021-08-17 for the period of 2011-02-01 to 2021-05-18.It 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 are unlikely.The product in question was produced on 2011-02-01.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.Further analysis is ongoing.A follow-up emdr will be submitted when additional information becomes available.

Event Description

The customer reported that the error message "ven.Bubble sensor defective" was displayed during patient treatment.No harm to patient was reported.Complaint id:(b)(4).

Event Description

Complaint id: (b)(6).

Manufacturer Narrative

The error message "ven.Bubble sensor defective" was reported.The device was being used for treatment.A getinge service technician investigated the unit on 2021-05-24 and 2021-06-01 and could not reproduce the failure.The technician performed safety, calibration, and functionality checks to factory specifications.For further analysis the log files for the reported event were analyzed by getinge life cycle engineering on 2021-08-02.It could be confirmed that the error message "ven.Bubble sensor defective" was logged several times for the date of event.The review of the non-conformities has been performed on 2021-08-17 for the period of 2011-02-01 to 2021-05-18.It 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 are unlikely.The product in question was produced on 2011-02-01.Based on the investigation results the reported failure "error message ven.Bubble sensor defective" could be confirmed.The exact root cause can not be determined, however following probable root causes can be linked to the reported failure according to the cardiohelp risk analysis: sensor disturbed by external electric or magnetic field (emi) or ultrasonic system environmental influences (atmospheric pressure, temperature, humidity, emi, over voltage).Sensor incorrect plugged.Deposits on connector.Intermittent sensor cable.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
• MDR Report Key: 12335574
• MDR Text Key: 267030996
• Report Number: 8010762-2021-00453
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K133598
• 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: 10/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2021
• 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
• Date Manufacturer Received: 10/06/2021
• Patient Sequence Number: 1