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 04/10/2020

Event Type  malfunction  

Manufacturer Narrative

The device was involved in that incident and not able to meet its specification.The reported failure was" venous bubble sensor giving a defective code".An impact to the therapy or harm to a patient was not reported.The reported behavior was already investigated in a similar complaint with the record #(b)4).As stated in the related life cycle engineering investigation report (dated 2020-04-28) the venous bubble sensor was connected to a reference cardiohelp.During boot up the error 0000a025 bubble sensor is defective was displayed.The sensor was not recognized by the cardiohelp.Probable root causes could be determined as: damaged cable due to mechanical tension.Damage due to overvoltage or esd (electrostatic discharge).Since the reported failure was observable, it could be confirmed.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: a "venous bubble sensor defective" error was reported.Issue occurred during patient treatment.No indication of actual or potential for harm or death.(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: 12346711
• MDR Text Key: 267423775
• Report Number: 8010762-2021-00466
• 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,u
• 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: UNKNOWN
• 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
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1