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

Model Number CARDIOHELP

Device Problem Pumping Problem (3016)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/15/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the cardiohelp showed the alarm ¿pump disposable error¿ during patient treatment.No indication of actual or potential for harm or death was reported.Complaint number: (b)(4).

Manufacturer Narrative

During patient transfer a "pump disposable error " message was reported.The device caused the complaint and was not able to work within factory specifications.As stated by the service and sales unit on 2020-12-16, the device had no malfunction.No service will be performed as the problem has been solved by phone.With reference to the current risk analyses u7.2.4.1 and u7.2.5.1 the following most probable root causes could be determined: user does not perceive or recognize how to correctly mount the transport guard the transport guard are mounted incorrectly or not mounted at all no coupling or insufficient coupling between the cardiohelp device and the disposable during transport.Additional condition: the mechanical impact on the cardiohelp device and disposable is too high.The ifu(instructions for use | 1.8 | en | 09) of the cardiohelp includes a warning under chapter 2 "do not remove the disposable product during normal operation." furthermore in the ifu (instructions for use | 1.8 | en | 09) it is stated in chapter 2.1.4 "please refor tho the respective instruction for use of the disposables".In reference of the current ifu for disposables (instructions for use | 1.5 | g-270 | 02) the following is stated in chapter 5.3.1 safety instructions for the oxygenator: incorrect installation of the hls module advanced can lead to device malfunction.This can endanger the patient.Use the device only together with the device cardiohelp-i.Install or remove the device only when the pump of the cardiohelp-i is at a standstill (0 rpm).Ensure that the device is fitted onto the device correctly and securely fixed, to eliminate the risk of magnetic decoupling between the drive and the centrifugal pump.Based on this the reported failure "pump disposable error" could be confirmed, but not a product related malfunction.The device history record (dhr) of the cardiohelp (material: 70104.8012, serial: (b)(6) for which a customer complaint was received, was reviewed on 2021-01-18.The dhr does not show any abnormality or issue that is related or can have led to the customer complaint.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: 11063602
• MDR Text Key: 225385011
• Report Number: 8010762-2020-00455
• 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: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• 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: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1