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 01/18/2023

Event Type  malfunction  

Manufacturer Narrative

A follow up will submitted when additional information become available.

Event Description

A flow/bubble sensor failure was reported during priming.Further information pending.No harm to any person has been reported.Complaint id: (b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

A flow/bubble sensor failure was reported.The male connector has a bent pin inside that plugs in to the device.The failure occurred during priming.A getinge field service technician (fst) was sent for investigation and repair on 2023-01-18 and 2023-01-23.He could confirm the failure and replaced the flow/bubble.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.It was confirmed by fst that the log files does not show a malfunction of the cardiohelp.Another flow/bubble sensor with a similar failure was visually investigated by getinge life-cycle-engineering.The most probable root causes are: pin grid was damaged.The connector was pushed with a lot of force into the port.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.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.The device was manufactured on 2019-10-08.The review of the non-conformities has been performed on 2023-0-06 for the period of 2019-10-08 to 2023-01-18.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.Based on the results the reported failure "bent pin of flow/bubble sensor" 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.

• 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: 16223118
• MDR Text Key: 308474137
• Report Number: 8010762-2023-00031
• 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: 02/07/2023

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: 701072780
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2023
• Initial Date FDA Received: 01/23/2023
• Supplement Dates Manufacturer Received: 01/23/2023
• Supplement Dates FDA Received: 02/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2019
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1