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

Model Number CARDIOHELP-I

Device Problem Communication or Transmission Problem (2896)

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

Event Date 04/15/2021

Event Type  malfunction  

Manufacturer Narrative

During patient treatment the error message "venous bubble sensor defective" appeared.A getinge service technician was sent for further investigation on 2021-04-15.According to service report id#(b)(4) the reported malfunction could be confirmed.After replacement of the venous bubble sensor, the device was able to work as per factory specifications (see service report id#(b)(4)).Based on this the reported failure could be confirmed.Probable root causes are determined within the investigation of record id# (b)(4) (dated 2020-02-21): damaged cable due to mechanical tension.Damage due to overvoltage or esd (electrostatic discharge).The occurrence rate was calculated for the reported failure 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

Reporting decision re-evaluated: the customer reported that the cardiohelp would alarm with "ven.Bubble sensor defective".Occurred during patient treatment.(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: 12346684
• MDR Text Key: 267431658
• Report Number: 8010762-2021-00462
• 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: consumer,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/19/2021

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: 08/02/2021
• Initial Date FDA Received: 08/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2020
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1