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

Model Number CARDIOHELP

Device Problem Pressure Problem (3012)

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 pressure failure was reported.New information received on 2020-12-03 that the customer changed the hls set to another cardiohelp.No indication for harm or death was reported.Complaintnumber:(b)(4).

Manufacturer Narrative

It was reported that the cardiohelp device displayed negative venous pressure after taking the patient for a ct scan.No external pressure sensor were attached.The user continued the treatment.No indication of actual or potential for harm or death was reported.A getinge field service technician has been sent for investigation.He could not reproduce the failure and no parts were replaced.The provided logfiles were investigated by life-cycle-engineering (lce) and our medical experts on 2020-01-26.The logfiles does not show any deviations and no failure regarding the reported failure venous pressure.Maquet cardiopulmonary requested the hls set for technical investigation.As it was disposed by the hospital, it is not available.The hospital stated that ¿initially the original hls was put onto a 2nd cardiohelp, it worked fine.It was then put back onto the original cardiohelp and also worked fine¿.Based on this a disposable related malfunction cannot be confirmed.Based on the evaluated facts above, the reported failure "negative venous pressure "could not be confirmed.However the failure mode "wrong pressure information" can be linked to the following most possible root causes according to our risk management file (dms# (b)(4)).Wrong plugged external pressure sensor or disconnection (mix up).Defective / disturbed (emi) pressure sensor.Defibrillator system.Laser scalpel.Rf system.Connection of non-compatible senor.Response time is too long.Defective pressure sensor.Positive or negative pressure beyond specification (release of tubes).Software error.External pressure sensor cannot be plugged.Too high / low.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: 10959477
• MDR Text Key: 220244800
• Report Number: 8010762-2020-00423
• 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,o
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2020
• 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: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1