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 11/30/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that the unit was giving an error "ven.Bubble sensor defective" while in use.They swapped out the cardiohelp.There was no patient harm reported.Complaint number: (b)(4).

Event Description

Complaintnumber: (b)(4).

Manufacturer Narrative

A "ven.Bubble sensor defective" message while in use was reported.Under service order report (b)(4) (dated on (b)(6) 2020) the service technician found that the venous bubble sensor is defective.The customer had a new sensor on-hand (s/n: (b)(6) ).So he completed a full system test with the new sensor installed.A replacement sensor has been ordered and will be kept as a new spare.The service technician completed a full calibration/functionality/and safety test and all tests passed to factory specifications.The device was returned to the customer and released for clinical use.A similar issue was already investigated under record idt# (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 (b)(4) 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 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.

• 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: 10934498
• MDR Text Key: 219157137
• Report Number: 8010762-2020-00417
• 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: 12/02/2020
• 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: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1