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

Model Number MCP00706037#ROTAFLOW ENGLISH EU-PLUG

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/15/2020

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 (b)(6) that a ¿reference error¿ occurred on the rotaflow console and the pump stopped during use.Also the customer smelt a burn-smell from the unit at that time.The machine checked the unit and found a burn-mark on the flow measurement board.The board was exchanged but the error ¿off set¿ occurred.Suspected that the power supply board might be damaged.The stated ¿reference error¿ and ¿off set¿ error are related with each other.(b)(4).

Manufacturer Narrative

The reported failure ¿reference error¿ and pump stop occurred on the rotaflow console during use.Followed by the error "off set" during testing the device.According to the service order dated on 2020-12-04 the 70101.1681 rfc flow measure board and 70101.1675 rfc power supply board has been replaced.The rotaflow has been testes according to the service protocol.Rfc passes all tests.Same failure was already investigated by the life- cycle-engineering (lce) in complaint (b)(4).In reference to lce report lce04109 dated on 2019-04-03.In the investigation the failure could be confirmed.It was discovered that a capacitor was defect.To determine which capacitor is defect every capacitor was unsoldered.The resistance was tested on the capacitor and the remaining circuit.The capacitor c10 was found to be defective.The capacitor was replaced.The fuse f2 and 3 were replaced on the power supply board to cross check the functionality.The device was tested for 23 hours.No more failure occurred.Most possible root cause could be determined as: a defect capacitor that led to a short circuit.This short circuit triggers the fuse f2 on the power supply board.The result is a pump stop and the error message offset is displayed.According to the statement of the life- cycle-engineering (lce) in the email dated on 2020-06-29 (see attachment) "the messages "error offset" and "error reference" are equivalent.Since the rotaflow can only display one message at a time, it depends on which one appears first in the system.With this combination (flow board and power supply board) the cause is a short circuit on the flow measurement board, which triggers the corresponding fuse on the power supply board.".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 failure ¿reference error followed by off-set error" and pump stop occurred on the rotaflow console during use 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

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
• MDR Report Key: 10739505
• MDR Text Key: 213187900
• Report Number: 8010762-2020-00356
• 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: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCP00706037#ROTAFLOW ENGLISH EU-PLUG
• Device Catalogue Number: 701043290
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/14/2020
• Patient Sequence Number: 1