MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH CARDIOHELP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number CARDIOHELP-I

Device Problems Device Sensing Problem (2917); No Flow (2991)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/05/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that there was an acoustic alarm "high priority alarm".The cardiohelp displayed the error message "arterial bubble sensor defective" and that the machine didn't appear to generate a flow even though the machine was set to 2300 rpms.The customer placed the cardiohelp into global override to re-establish flow.The pressure values were within normal limits.The flow bubble sensor was exchanged.The replacement sensor worked initially without any issue but eventually began to give the same error message of "arterial bubble sensor defective." the patient was actively being weaned off support when this issue occurred, so the patient tolerated being off support temporarily and vital signs were stable when pump stopped.Later on this same day the patient was weaned off the cardiohelp support completely.The customer also reported that the same issue occurred when initiating support on this patient but the issue resolved and went away on its own.Complaint id: (b)(4).

Manufacturer Narrative

The customer reported that there was an error message "arterial bubble sensor defective" and that the machine didn't appear to generate a flow even though the machine was set to 2300 rpms.The failure occurred during treatment.The customer placed the cardiohelp into global override to re-establish flow.The pressure values were within normal limits.The flow bubble sensor was exchanged.The replacement sensor worked initially without any issue but began to give the same error message of "arterial bubble sensor defective." the patient was actively being weaned off support when this issue occurred, so the patient tolerated being off support temporarily and vital signs were stable when pump stopped.Later on this same day the patient was weaned off the cardiohelp support completely.The customer also reported that the same issue occurred when initiating support on this patient but the issue resolved and went away on its own.A getinge field service technician (fst) was sent for investigation and repair on 2022-12-09.The reported failure could not be replicated.No failure with the arterial flow bubble sensor could be identified.No parts were replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.The log file review was performed on 2022-12-20.It could be confirmed that on 2022-12-05 multiple "arterial bubble sensor defective" error messages and a pump stop message were logged.An exact root cause could not be determined, as the failure could not be replicated by the getinge field service technician.According to the risk file v24 of the cardiohelp device the 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.The review of the non-conformities has been performed on 2022-12-20 for the period of 2020-06-17 to 2022-12-05.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 manufactured on 2020-06-17.Based on the results the reported failure "arterial bubble sensor defective error" could be confirmed through the log files.However no device malfunction was identified.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: 15994654
• MDR Text Key: 306283127
• Report Number: 8010762-2022-00503
• 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
• Report Date: 12/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• 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
• Date Manufacturer Received: 12/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1