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

Model Number CARDIOHELP

Device Problem Communication or Transmission Problem (2896)

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

Event Date 11/10/2022

Event Type  malfunction  

Event Description

During inhouse repair a defective flow/bubble was reported.Technician was unable to zero the flow/bubble sensor during calibration.No harm to any person has been reported.Complaint id: (b)(4).

Manufacturer Narrative

A follow up will submitted when additional information become available.

Event Description

Complaint id:(b)(4).

Manufacturer Narrative

A getinge field service technician (fst) was sent for investigation and repair on 2022-11-10.The flow/bubble sensor was replaced.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 2022-11-15.There is no indication that manufacturing issues occurred, thus production related influences are unlikely to have contributed to the reported failure.A follow up will submitted when additional information become available.

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

A defective flow/bubble was reported.The failure occurred during inhouse repair and the getinge technician was unable to zero the flow/bubble sensor during calibration.A getinge field service technician (fst) was sent for investigation and repair on 2022-11-10.The flow/bubble sensor was replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.The provided log files show the error message "arterial bubble detected" several times on the reported date of event 2023-11-10, which could not be zeroed.It was confirmed by the getinge technician that the flow bubble sensor in question did not have any visible damage on the sensor or its cable.The affected flow/bubble sensor was inspected by getinge life-cycle-engineering (lce) on 2023-02-17.It can be concluded that reported failure could be traced back to an already performed technical investigation of the lce.Another flow/bubble sensor was investigated by getinge life-cycle-engineering (lce) on 2023-01-27.The fluctuating of the zero flow could be reproduced.In specific pairing of the flow/bubble sensor with the sensor panel, fluctuations can be observed.In order to investigate this behavior the supplier em-tec initiated a capa.- the inspection of the complete stock did not reveal any other anomalies.The 100% inspection focused on bent pins, insufficient solder joints, and the overall appearance of the boards.- submitted boards with the behavior occurring were studied in detail.In individual cases, the behavior described by the customer could be reproduced.- no deviations or non-conformities on boards or the sensors were apparent to explain the error behavior.All boards and sensors are technically flawless - the misconduct occurs only in individual cases.The cause is attributed to a chain of unfavorable factors.- the products do not show any visible technical defects.Moreover in the instruction for use chapter 5.3.1 connecting the combined flow/bubble sensor is stated that 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 device was manufactured on 2020-11-24.The device history record of the cardiohelp was reviewed on 2022-11-15.There is no indication that manufacturing issues occurred, thus production related influences are unlikely to have contributed to the reported failure.Based on the results the reported failure "defective 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: 15787114
• MDR Text Key: 305376934
• Report Number: 8010762-2022-00447
• 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,Followup
• Report Date: 02/23/2023

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
• Device Catalogue Number: 701072780
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2022
• Initial Date FDA Received: 11/14/2022
• Supplement Dates Manufacturer Received: 11/15/2022; 02/17/2023
• Supplement Dates FDA Received: 12/02/2022; 02/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1