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 06/20/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A flow/bubble sensor alarm was reported.The instant of time was not provided.No harm to any person has been reported.Complaintnumber: (b)(4).

Event Description

Complaint number: (b)(4).

Manufacturer Narrative

A getinge service technician (fst) was sent for investigation and repair on 2022-08-02.No parts were replaced and the fst could not reproduce any bubble sensor alarms.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.The device history record (dhr) of the cardiohelp (material: 701072780, serial: (b)(6) was reviewed on 2022-06-22.There is no indication that manufacturing issues occurred, thus production related influences are unlikely to have contributed to the reported failure.

Event Description

Complaintnumber: (b)(4).

Manufacturer Narrative

A flow/bubble sensor alarm was reported.The event occurred during priming.The provided logs files does not include the reported date of event 2022-06-20.Further information are requested, but could not be provided by customer.Thus, an exakt root cause could not be identified.However, according to the risk file v24 (dms# 2021972) following root causes can lead to the reported failure; influence due to other ultrasonic devices (e.G.Flow sensor).Bubble sensor not plugged but recognized.Connection of non-compatible sensor.Environmental influences (atmospheric pressure, temperature, humidity, emi, over voltage).Sensors are disturbed by external electric or magnetic field (emi) or ultrasonic system.According to the instruction for use 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.Furthermore, according to the instructions for use (ifu) of the cardiohelp (chapter 10 cleaning and disinfection) the cables and the whole device should be cleaned after each use to remove soiling or residual blood.Furthermore in chapter 5.3 connecting the sensors it is stated that the sensors must be kept clean.Based on the investigation results the reported failure "flow/bubble sensor alarm." could not 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.

• 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: 14789087
• MDR Text Key: 294599087
• Report Number: 8010762-2022-00239
• 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,Followup
• Report Date: 10/05/2022

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: 701072780
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/20/2022
• Initial Date FDA Received: 06/23/2022
• Supplement Dates Manufacturer Received: 08/11/2022; 09/27/2022
• Supplement Dates FDA Received: 09/05/2022; 10/05/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/24/2021
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1