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

Model Number CARDIOHELP

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/23/2020

Event Type  malfunction  

Manufacturer Narrative

A follow up will be submitted when additional information becomes available.

Event Description

The following was reported: "during use shortly after initiation of support customer states that cardiohelp momentarily flashed red alarm.Checking alarm history shows message "venous bubble detector defective" venous bubble detector was tested with intervention off and did alarm.It was left in place, but alarm repeated several hours later.Customer is moving disposable to another cardiohelp drive system." complaint number: (b)(4).

Manufacturer Narrative

During use the error message "venous bubble detector defective" occurred.Thus the device was directly involved in the event and caused the complaint.No negative outcome to the patient was reported.Under service order report (b)(4) (dated on 2020-12-11) the defective venous bubble sensor was replaced.After replacement the unit passed all tests and was cleared for clinical use.A similar issue was already investigated under record idt# (b)(4).The venous bubble sensor was investigated by (b)(4) on 2020-04-28.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 (b)(4) 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 the reported failure "venous bubble detector defective" could 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.

Event Description

Complaintnumber: (b)(4).

• Brand Name: HEART LUNG MACHINE
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 10910513
• MDR Text Key: 219174683
• Report Number: 8010762-2020-00403
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CARDIOHELP
• Device Catalogue Number: 70104.8012
• Date Manufacturer Received: 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1