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

Model Number MCP00706291#ROTAFLOW CHINESE ZH-PLUG

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported from a customer from (b)(6) ,that on the rotaflow console, the error ¿reference¿ occurred after booting the device.The machine cannot operate normally, which is suspected by a failure of the flow measurement board.Complaint id: (b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

The reported error ¿referenc¿ occurred after booting the device.According to the service order 43456839 dated on 2020-09-19 error "reference" occurred after booting.After replacing the 70101.1681 rfc flow measure board the alarm disapeared and the machine worked normally.The reported failure "error referenc" was already investigated by our lce in complaint 705007074.Most probable root causes could be determined: the condensator c109 has a partial break-through which overloads the voltage converter which lead to the reported error.The reported failure "error refferenc " occurred during after booting the device 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.

• 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
• MDR Report Key: 10552669
• MDR Text Key: 207514975
• Report Number: 8010762-2020-00303
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• PMA/PMN Number: K991864
• 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: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCP00706291#ROTAFLOW CHINESE ZH-PLUG
• Device Catalogue Number: 701046405
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/21/2020
• Patient Sequence Number: 1