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 05/25/2023

Event Type  malfunction  

Manufacturer Narrative

A getinge service technician will investigate the affected cardiohelp.A follow-up medwatch will be submitted when additional information becomes available.

Event Description

It was reported that the arterial flow/bubble sensor was not recognized by the cardiohelp.No harm to any person has been reported.Complaint id# (b)(4).

Manufacturer Narrative

The failure occurred during training.A getinge field service technician (fst) was sent for investigation and repair on 2023-06-28/29.The fst verified that an arterial bubble sensor defective error message comes up, when a few different flow/bubble sensor were attached.The sensor panel will be replaced.The rotary encoder was replaced due to precaution.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.A follow-up medwatch will be submitted when additional information becomes available.

Event Description

Complaint id# (b)(4).

Manufacturer Narrative

It was reported that the arterial bubble sensor does not communicate with the cardiohelp unit.The failure was found during training.The flow/bubble sensor was not damaged and there was no dirt on the sensor.The error message "flow/bubble sensor defective" was displayed.A getinge field service technician (fst) was sent for investigation and repair on 2023-06-28/29.The fst verified that an arterial bubble sensor defective error message comes up, when a few different flow/bubble sensor were attached.The sensor panel will be replaced.The log files of the reported cardiohelp device were reviewed and the error message "flow-bubble sensor defective" could be confirmed on the date of event.According to getinge life cycle engineering (lce) following most probable root causes can lead to the error: - an unreliable plug connection on the digiflow mini-board led to the error.- eprom on the flow/bubble sensor was not readable.Moreover, in the instruction for use (ifu) chapter 5.3.1 "connecting the combined flow/bubble sensor" is stated that the bubble monitoring function test and flow off-set calibration has to be performed before every use.Thus a defective flow/bubble sensor should be detected prior to use, during priming.The review of the non-conformities has been performed on 2023-05-30 for the period of 2017-06-27 to 2023-05-25.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 device was manufacture on 2017-06-27.Based on the results the reported failure "flow bubble sensor not recognized" could be confirmed.The customer will be informed about the results by the getinge sales and service unit.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

Complaint id (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: 17028618
• MDR Text Key: 316224340
• Report Number: 8010762-2023-00252
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/11/2023

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: 05/25/2023
• Initial Date FDA Received: 05/31/2023
• Supplement Dates Manufacturer Received: 06/30/2023; 08/08/2023
• Supplement Dates FDA Received: 07/19/2023; 08/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1