MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HEART LUNG MACHINE; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number MCP00706041#ROTAFLOW ENGLISH/UK UK-PLUG

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 12/10/2020

Event Type  malfunction  

Manufacturer Narrative

The reported "head error" occurred during installation.According to the part remove grid in the complaint the (b)(4) rf control board has been replaced.The following most possible root cause could be determined for the head error: the head error is caused by the hot plug.When the device is in operation and the power plug is plugged in or out the head error occurs and the rota flow drive and / or the control board is damaged.As a result the rota flow drive and / or the control board has to be replaced.Furthermore, the instructions for use of the rotaflow system, see rotaflow system instruction for use, instructions for use | 4.2 | en | 13, chapter 8.1.2 contain detailed descriptions to prevent an ¿error head¿.The device history record (dhr) was performed and the dhr does not show any abnormality or issue that is related or can have led to the customer complaint.The reported "head error" occurred during installation and 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.

Event Description

It was reported from (b)(6) that a ¿head error¿ occurred during the installation of the rotaflow console.Head error is coming after 1000 rpm.No patient involvement.No indication of actual or potential for harm or death reported.Complaint id: (b)(4).

• Brand Name: HEART LUNG MACHINE
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• Manufacturer (Section G): NURSEL BOELENS; maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; 4972229321
• MDR Report Key: 11051770
• MDR Text Key: 223147255
• Report Number: 8010762-2020-00443
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K991864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCP00706041#ROTAFLOW ENGLISH/UK UK-PLUG
• Device Catalogue Number: 701043291
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2019
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1