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

Model Number CARDIOHELP-I

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 10/24/2022

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 cable was detached from the flow/bubble sensor.The customer is unsure how this happend but is assuming that this was caused by external force.No pump stop occurred and there was no delay in treatment.As well as no error message occurred.The failure occurred during set-up.No harm to any person has been reported.(b)(4).

Manufacturer Narrative

It was reported that the cable was detached from the flow/bubble sensor.No pump stop occurred and there was no delay in treatment.The failure occurred during set-up.A getinge field service technician (fst) was sent for investigation and repair on 2022-10-28.The flow/bubble sensor was replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.Furthermore the logfile analysis shows no error message or pump stop.The fst stated that the most probable root cause are external forces as communicated by the customer.According to the risk analysis of the cardiohelp device following root causes can also lead to the reported failure: user puts force on the device accessories, user does not properly attach the device components, fail of device by mechanical force caused by wear/ loosening of components.Moreover, 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 2022-10-28 for the period of 2013-05-01 to 2022-10-24.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 2013-05-01.Based on the results the reported failure "arterial flow bubble sensor has become separated from its cable" could be confirmed.The customer will be informed about the results by the getinge sales and service unit.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.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.

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: 15697939
• MDR Text Key: 304347978
• Report Number: 8010762-2022-00428
• 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: 12/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2022
• 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: 701048012
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1