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 08/29/2023

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 flow/bubble sensor was faulty.The failure occurred during treatment.No harm to any person has been reported.Complaint id # (b)(4).

Manufacturer Narrative

It was reported that the flow/bubble sensor was faulty and displayed erratic values.According to the customer the flow/bubble sensor does not fully close.The failure occurred during treatment.The treatment was continued without exchanging the cardiohelp device.A getinge field service technician (fst) was sent for investigation and repair on 2023-09-06 and 2023-09-20.The fst could not replicate the failure and completed a function check on the faulty flow/bubble sensor without issue, but said that the sensor is extensively used and worn.The flow/bubble sensor was replaced as a precautionary measure.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.The log files of the reported cardiohelp device were reviewed and the failure could not be confirmed on the date of event.According to the fst the most possible root cause is a mechanical damage due to frequent use and wear and tear.Referring to the instruction for use (ifu) of the cardiohelp, chapter 5.3 "connection the sensors", it is stated to ensure that the connected sensors are not defective and to not use if there is a visible damage.In the ifu, chapter 5.3.1 "connecting the combined flow/bubble sensor" the bubble monitoring function test and flow off-set calibration must 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.Additionally, according to the ifu chapter 6.4.4 "using the emergency drive with the disposable hls retainer" is stated that the emergency drive can be used to manually control the blood flow in case of a failed cardiohelp.The review of the non-conformities has been performed on 2023-08-31 for the period of 2020-03-07 to 2023-08-29.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 2020-03-07.Based on the results the reported failure "flow bubble sensor has erratic values" could not be replicated, but confirmed.The customer will be informed about the results by the getinge sales and service unit.This complaint was found in the database of customer complaints for the cardiohelp device as a single event (2022-08-01 and 2023-08-01).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

Complain 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: 17649571
• MDR Text Key: 322257025
• Report Number: 8010762-2023-00433
• 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: 09/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2023
• 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: 09/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1