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

Model Number CARDIOHELP-I

Device Problems Improper or Incorrect Procedure or Method (2017); Infusion or Flow Problem (2964)

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

Event Date 10/03/2023

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 output pressure was negative.No harm to any person has been reported.Complaint id # (b)(4).

Manufacturer Narrative

It was initially reported that the output pressure was negative.The failure occurred during priming.According to the customer, the failure was operator error that could not be corrected once ecls flow was initiated.During priming, zeroing of pressure was omitted in error as treatment was initiated rapidly.Zeroing of the pressure was attempted twice during treatment but was unsuccessful due to the interventions set.The pressure was monitored with an external transducer.No harm to either patient or operator.A getinge field service technician (fst) was sent for investigation and repair on 2023-10-03.No parts were replaced.The fst could not replicate the failure.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.Pump stops and part, pven, pint, tart, tven sensors disconnected could be confirmed on the date of event, 2023-10-03.According to the customer, the root cause was operator error, as zeroing pressure was omitted during priming, referring to the instructions for use (ifu) of the cardiohelp, chapter 5.5.1 ¿integrated pressure sensors: carrying out zero calibration¿, the calibration must be performed with an empty system.The system must be free of liquids for calibrating the integrated pressure sensors.For this reason, carry out the calibration before priming.Otherwise, the calibration may produce incorrect measurements, which cause false value displays, alarms, and interventions.Furthermore, 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.Additionally, according to the ifu 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.The review of the non-conformities has been performed on 2023-10-12 for the period of 2014-01-29 to 2023-10-03.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 2014-01-29.Based on the results the reported failure " output pressure was negative " could be confirmed, but is not related to a malfunction of the device.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.

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: 17885251
• MDR Text Key: 325075830
• Report Number: 8010762-2023-00490
• 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: 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2023
• 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: 10/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2014
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1