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

Model Number 701046405 - ROTAFLOW CHINESE ZH-PLUG

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 04/24/2020

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 from (b)(6) that error txrx occurred after this rotaflow was switched on.The flow measure board was broken.Complaint id: (b)(4).

Manufacturer Narrative

The "txrx error" occurred before using the device.According to the communication grid in the complaint dated on 2020-05-05 the flow measurement board (701011681) has been replaced.The reported failure is already known and investigated in our life cycle engineering with the following result: the txrx-error was related to a defective flow measurement board (fmb).It could be determined by investigations by life cycle engineering (lce) of identical fmb¿s in other complaints.According to investigation report lce 2827 (investigation performed on 2015-11-18, refer to complaint sap record#(b)(4)) the capacitor c2 had a short circuit.Due to that the ¿-12 v failure¿ appeared and the fuse f1 was triggered.According to lce 3852 (investigation performed on 2018-07-12, refer to trackwise record#162681) the fmb was damaged by a service technician.When removing it the soldering joint of potentiometer pot3 was broken.Other malfunctions of the fmb, the rotaflow drive or wires would lead to the error messages ¿----¿ or ¿-**-¿ on the flow display.Thus other components can be excluded as probable root cause.The failure could be confirmed.The most probable root cause for the "txrx error" could be a internal short circuit in the capacitor c2.The "txrx error" occurred before using 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.

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: 10013897
• MDR Text Key: 200699789
• Report Number: 8010762-2020-00147
• 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: 05/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 701046405 - ROTAFLOW CHINESE ZH-PLUG
• Device Catalogue Number: 701046405
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/05/2020
• Patient Sequence Number: 1