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

Model Number CARDIOHELP

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The following was reported: "i was told today by the cardio technology department that on (b)(6) 2020, a patient with diagnosed pneumonia who was already in the weaning process had an incident with a stoppage of the extracorporeal blood flow during a v-v-ecmo.The ecmo had been connected for 10 days.The patient was being woken up.The patient was in a stable state at a speed of 2000 rpm and the blood flow generated by it of 2 lpm.When the patient was checked, it was discovered that the extracorporeal blood flow had stagnated: the number of revolutions was still 2000 rpm, but the flow indicator was 0 lpm with serous blood in the tubes.The doctor who was called clamped off the tubes and pulled out the cannulas.Therapy could not be continued with this system.The lower blood flow alarm limit was deactivated at the time, so that no alarm could be triggered by falling below a flow limit.The patient had an increase in blood pressure to 150/80 mmhg.In the past few days, anticoagulation was stable between 50 and 60 s; when it occurred it was currently 53 s.No clots could be detected macroscopically.The tubing set including cannulas, centrifuge and oxy has already been discarded.The patient survived the discontinuation of therapy in a stable manner - without a new ecmo." complaint number: (b)(4).

Manufacturer Narrative

A flow stop during patient treatment was reported and the device was directly involved in the event.As stated by the service and sales unit (ssu) in the communication grid on 2020-12-08 the device was checked by a getinge service technician in the hospital.As informed from the ssu the device had no malfunction and is back in use.The service technician found, that the customer had not activated the lower limit alarm.The customer was advised how important it is activating alarm settings.In the instruction for use (instructions for use | 1.8 | en | 09) under chapter 6.2.1 flow monitoring the following is stated: "this function monitors the blood flow.For this purpose, warning limits must be set.".Based on this the reported failure "flow stop" could be confirmed, but no product related malfunction.The most probable root cause could be determined as a handling failure by user.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: 11075584
• MDR Text Key: 223726416
• Report Number: 8010762-2020-00459
• 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
• Type of Report: Initial,Followup
• Report Date: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2020
• 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: 12/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 120