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

Model Number CARDIOHELP-I

Device Problems Inaccurate Flow Rate (1249); Increase in Pressure (1491)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/24/2023

Event Type  malfunction  

Event Description

It was reported that there was a pressure reading issue.All pressure values increased after one hour of runtime, whereas the delta pressure was not higher than 1 and the flow could not be increased past 1 liter per minute.No harm to any person has been reported.(b)(4).

Manufacturer Narrative

A follow-up medwatch will be submitted when additional information becomes available.

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

It was reported that there was a pressure reading issue.After one hour of support all pressures increased to 5020mmhg whereas the delta pressure was 1 and the maximum flow was 1 liter per minute.The failure occurred during use.A getinge field service technician (fst) was sent for investigation and repair on 2023-05-31.The failure could not be replicated and no parts were replaced.The device was tested without any changes in pressure or flow.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 no failures could be confirmed on the date of event.The corresponding hls set is not available for investigation as it is scrapped by the customer.However, according to the risk file v24 of the cardiohelp device the following root cause can also lead to the reported failure: unexpected no or low rpm by flow intervention (only step 1): upper flow intervention too low wrong pressure information e.G.: disturbed (emi) pressure sensor, response time is too long, defective pressure sensor, too high / low atmospheric pressure.According to the instruction for use of the involved disposables (hls set advanced 5.0 / 7.0, hit set advanced 5.0 / 7.0, v2.4, chapter 6.1 preparation and installation and quadrox-ir small adult / adult, chapter 7.2 priming the system) the pressure sensors have to be calibrated and checked before priming.Further the cardiohelp has a flow/bubble sensor and a venous probe 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 2023-06-29 for the period of 2019-12-04 to 2023-05-24.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 2019-12-04.Based on the results the reported failure "increased pressure values and no adjustment of flow possible" could not 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: 17018678
• MDR Text Key: 316099631
• Report Number: 8010762-2023-00248
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2023
• 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: 701048012
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2019
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1