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

Model Number CARDIOHELP-I

Device Problems Structural Problem (2506); Communication or Transmission Problem (2896)

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

Event Date 06/03/2021

Event Type  malfunction  

Manufacturer Narrative

A follow up will be submitted, when additional information become available.Investigation is ongoing.

Event Description

Reporting decision re-evaluated: a "venous bubble sensor defective" error and a frayed venous probe cable was reported.Issue occurred during patient treatment.No indication of actual or potential for harm or death was reported.Complaint number:(b)(4).

Manufacturer Narrative

A "venous bubble sensor defective" error was reported.The failure occurred during patient treatment and caused the complaint.A getinge field service technician was sent for investigation on 2021-06-03/04.He could confirm the failure and replaced the venous bubble sensor.The unit was tested an but back in use.A similar venous bubble sensor was already investigated within another complaint (#(b)(4)).As stated in the investigation report the malfunction could be confirmed.The venous bubble sensor was connected to a reference cardiohelp.During boot up the error 0000a025 bubble2 sensor is defective was displayed.The sensor was not recognized by the cardiohelp.The affected sensor was sent to the supplier sonotec gmbh on 2020-02-21 (rma20-101072) to determine the root cause.Sonotec gmbh confirmed the failure.According to their investigation the sensor is electrically damaged.Following possible root causes were determined: damaged cable due to mechanical tension, damage due to overvoltage or esd (electrostatic discharge), based on this results, the reported failure "venous bubble sensor defective" 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

Complaintnumber: (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
• MDR Report Key: 12346891
• MDR Text Key: 267425112
• Report Number: 8010762-2021-00467
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K133598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 09/03/2021

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: 701048012
• Initial Date Manufacturer Received: 08/18/2021
• Initial Date FDA Received: 08/20/2021
• Supplement Dates Manufacturer Received: 08/18/2021
• Supplement Dates FDA Received: 09/06/2021
• Patient Sequence Number: 1