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

Model Number CARDIOHELP-I

Device Problem No Flow (2991)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

(b)(4).It was reported that during patient treatment two cardiohelps had a problem to flow.Only with the emergency drive the flow values were in an adequate range.The problem could be solved by restarting the unit.

Manufacturer Narrative

According to the service technician a full preventive maintenance was performed for both units and no failure was found.The log files were showing a bubble alarm followed by "no disposable detected".After that the error "pump disposable error - stop" occurred.This error will be triggered if the rounds per minutes (rpm) are not put to zero before the disposable is disconnected and connected again.It can be corrected by putting the rpm to zero or restarting the cardiohelp.According to the files the customer switched to another cardiohelp unit.On the second cardiohelp the same failure ("pump disposable error - stop") occurred as well as backflow prevention alarms.After the unit was re-started it worked normally till therapy was finished.As no problem was found on both units and the disposable worked normally no malfunction of the products could be confirmed.The most probable root cause is an user error.After talking to the customer the service technician stated that the failure occurred due to a mispositioning of the disposable.In the cardiohelp instruction for use (ifu, v1.8) is stated that it is necessary to decrease the flow to zero before starting the pump after the disposable was disconnected.Otherwise it will lead to a pump disposable error.The occurrence rate was calculated for the reported failure 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: 10212990
• MDR Text Key: 197551415
• Report Number: 8010762-2020-00214
• 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
• Type of Report: Initial,Followup
• Report Date: 08/03/2020

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-I
• Device Catalogue Number: 70104.8012
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 06/20/2020
• Initial Date FDA Received: 06/30/2020
• Supplement Dates Manufacturer Received: 07/27/2020
• Supplement Dates FDA Received: 08/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention