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

Model Number CARDIOHELP-I

Device Problems Infusion or Flow Problem (2964); No Flow (2991)

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

Event Date 09/06/2022

Event Type  malfunction  

Event Description

It was reported that the rotation per minute (rpm) of the pump went from 3000 to zero and that they could not be increased.Instance of time was not reported.No harm to any person has been reported.(b)(4).

Manufacturer Narrative

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

Event Description

It was reported that the rotation per minute (rpm) of the pump went from 3000 to zero and that they could not be increased.The customer exchanged the cardiohelp.The failure occurred during treatment.No harm to any person has been reported.Complaint id: (b)(4).

Manufacturer Narrative

The investigation is ongoing.A getinge field service technician (fst) was sent for investigation and repair on 2022-11-15 and 2022-12-06.The failure could not be replicated and no parts were replaced related to this issue.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.The review of the non-conformities has been performed on 2022-12-12 for the period of (b)(6) 2019 to (b)(6) 2022.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 2019-11-01.A follow-up medwatch will be submitted when additional information becomes available.

Manufacturer Narrative

It was reported that the rotation per minute (rpm) of the pump went from 3000 to zero and that they could not be increased.The failure occurred during treatment.The customer exchanged the cardiohelp.A getinge field service technician (fst) was sent for investigation and repair on 2022-11-15 and 2022-12-06.The failure could not be replicated and no parts were replaced related to this issue.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.No abnormal error messages were logged that could explain the reported event on 2022-09-06.No exakt root cause could be determined, because the failure could not be replicated be the getinge field service technician.However, according to the risk file v24 of the cardiohelp the following root causes can lead to the reported failure: - influence due to other ultrasonic devices (e.G.Flow sensor) - connection of non-compatible sensor - environmental influences (atmospheric pressure, temperature, humidity, emi, overvoltage the hls set was not available, because the customer did not retain it.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.The review of the non-conformities has been performed on 2022-12-12 for the period of 2019-11-01 to 2022-11-07.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 2019-11-01.Based on the results the reported failure "3000 to zero and that they could not be increased " could not 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: 15778620
• MDR Text Key: 304349240
• Report Number: 8010762-2022-00446
• 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: 01/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2022
• 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: 01/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2019
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1