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

Model Number CARDIOHELP-I

Device Problems Incorrect Measurement (1383); Failure to Calibrate (2440); Communication or Transmission Problem (2896)

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

Event Date 08/24/2021

Event Type  malfunction  

Manufacturer Narrative

A follow up will be submitted when additional information become available.A getinge service technician will be investigate the unit in question.

Event Description

It was reported that the venous probe was not reading values properly.Also the touchscreen lost calibration and the bubble detector alarmed and stopped the pump.No indication of actual or potential for harm or death.Information received that the device was changed due to the pump stop as result of the reported "flow bubble sensor failure".Complaint number: (b)(4).

Event Description

Complaint number: (b)(4).

Manufacturer Narrative

It was reported that the venous probe was not reading values properly.Also the touchscreeen lost calibration and the bubble detector alarmed and stopped the pump.For all reported failures: the device was manufactured on 2020-11-05.The device history record (dhr) of the cardiohelp (material: 701072780, serial: (b)(6), elo#: 1096260/v1) was reviewed on 2021-11-26.There is no indication that manufacturing issues occurred, thus production related influences are unlikely to have contributed to the reported failure.A getinge service technician was sent for investigation on 2021-08-26.He could not confirm any malfunctions.The unit was tested and put back in use.The logfiles of the cardiohelp were analysed by getinge-life-cycle-engineering on 2021-09-28.The logfiles does not show any malfunction of the cardiohelp.In regards to the failure "venous probe not reading values properly" an exalt root cause could not be determined.However, the following causes could be linked to the reported failure: defective / disturbed (emi) sensor measurement wrong measurement values caused by sediments in the disposable response time is too long light influences blood light spectrum differences.For the reported failure "touchscreeen responding not correctly" also an exact root cause could not be determined.However, with reference to the current risk file the failure was most possible caused by "lost touch calibration".In regards to the failure "bubble detector alarmed and stopped the pumped" an exact root cause could not be determined.However, the following causes could be linked to the reported failure: wrong bubble sensor information influence due to other ultrasonic devices (e.G.Flow sensor) bubble sensor not plugged but recognized connection of non-capatible sensor environmental influences (atmospheric pressure, temperature, humidity, emi, overvoltage).Based on this investigation results the reported failures could not be confirmed.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: 12376470
• MDR Text Key: 268425608
• Report Number: 8010762-2021-00479
• 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: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2021
• 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
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 12/21/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/05/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Sex: Male