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

Model Number CARDIOHELP

Device Problem Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A defective venous bubble sensor cable failure was reported.On (b)(6) 2020 new information received that the customer swapped the unit during patient treatment.Complaint number: (b)(6).

Manufacturer Narrative

A defective venous bubble sensor, cable failure, was reported.According to the service order report #(b)(4) the technician was unable to duplicate the complaint with the defective venous bubble sensor.Under this service order report the technician replaced the 701073922 ch user interface hardware update kit.This failure will be investigated in the related complaint#(b)(4).After replacement the unit passed all tests per service manual.This work were performed on 2020-10-19/20/22.Thus the reported failure "defective venous bubble sensor" could not be confirmed.A similar issue was already investigated under complaint#(b)(4).The venous bubble sensor was investigated by life cycle engineering (lce) 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 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).The second failure with the touch panel will be handled in the already opened complaint ot#(b)(4).The failure occured during patient treatment and the device was directly involved in the incident.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

Complaint number: (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: 10768753
• MDR Text Key: 214148740
• Report Number: 8010762-2020-00367
• 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: consumer,foreign,health profe
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 11/10/2020

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
• Device Catalogue Number: 701048012
• Initial Date Manufacturer Received: 10/12/2020
• Initial Date FDA Received: 11/02/2020
• Supplement Dates Manufacturer Received: 10/27/2020
• Supplement Dates FDA Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1