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 01/11/2022

Event Type  malfunction  

Event Description

A flow/bubble sensor failure was reported.The information received, that the pump stopped for only a few seconds.No harm to any person has been reported.Complaint number: (b)(4).

Manufacturer Narrative

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

Manufacturer Narrative

A flow/bubble sensor failure was reported.The pump stopped for only a few seconds.The clinician at the bedside recognized immediately what was wrong and the patient was off support for only a few seconds with no lasting adverse effects.Customer decided to tape the flow/bubble sensor closed at this time.No harm to any person was taken place.As confirmed by getinge service and sales unit on 2022-01-14 a flow/bubble sensor will be sent to customer.The customer will replace the defective sensor by themselves.The affected flow/bubble sensor was not available for technical investigation.Thus, an exact root cause could not be determined.However, according to getinge product experts the most probable root causes are: - latching groove is either worn or contaminated; - the snap lever does not have sufficient lateral play in its groove (caused by clamping due to contamination); - the tongue of the snap lever is worn.Furthermore, according to the instruction for use (ifu, chapter 5.3.1 connecting the combined flow/bubble sensor) 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.In addition as the cardiohelp includes pressure sensors and a venous probe it is able to measure and control the blood flow and parameters.If the measured values are above high limit or below low limit of the set limits the system generates a visual and acoustical alarm.Based on this investigation results, the reported "flow/bubble sensor failure" could be confirmed.The review of the non-conformities has been performed on 2022-01-27 for the period of 2015-10-09 to 2022-01-12.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 to have contributed to the reported failure.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

Complaintnumber: (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: 13248182
• MDR Text Key: 283749364
• Report Number: 8010762-2022-00005
• 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: 03/02/2022

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: 01/11/2022
• Initial Date FDA Received: 01/13/2022
• Supplement Dates Manufacturer Received: 02/22/2022
• Supplement Dates FDA Received: 03/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1