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

Model Number CARDIOHELP-I

Device Problems Calibration Problem (2890); Pressure Problem (3012)

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

Event Date 11/13/2023

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 pven was out of the calibration tolerance.The failure occurred during maintenance.Complaint id # (b)(4).

Event Description

Complaint id # (b)(4).

Manufacturer Narrative

It was reported that the pven was out of the calibration tolerance.It was later reported that the failure was due to moisture in testing equipment, causing readings that were out of tolerance.The failure occurred during maintenance.A getinge field service technician (fst) was sent for investigation and repair.No parts were replaced.According to the fst, the failure was due to moisture in the testing equipment.No failure were reported on the cardiohelp.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.The root cause according to the fst was faulty testing equipment, refer to attachments).Additionally, according to the risk file v24 of the cardiohelp device the following root causes can lead to the reported failure: device is not regularly or is wrongly serviced / maintained / repaired e.G.: - error of service module as stated in the service manual of the cardiohelp device (cardiohelp system, service requirements) only authorized service technicians are allowed to carry out service-related work.Thus, the issue can only occur during service of an authorized service technician.Further according to chapter 3.1 "general information" the device must be checked after every maintenance or repair.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.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.The device was manufactured on (b)(6) 2022.The device history record (dhr) of the cardiohelp (material: (b)(4), serial: (b)(6)) was reviewed on 2023-11-21.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 "pven out of tolerance ¿ service related issue" could be confirmed.This complaint was found in the database of customer complaints for the cardiohelp device as a single event (timeframe from 2022-11-13 till 2023-11-13).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: 18137657
• MDR Text Key: 328123129
• Report Number: 8010762-2023-00570
• 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: 02/16/2024

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-I
• Device Catalogue Number: 701072780
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2023
• Initial Date FDA Received: 11/15/2023
• Supplement Dates Manufacturer Received: 02/14/2024
• Supplement Dates FDA Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2022
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1