MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH ROTAFLOW CENTRIFUGAL PUMP SYSTEM; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number MCP00703163#RFC 20-970ROTAFLOW CONSOLE

Device Problems Off-Label Use (1494); Use of Device Problem (1670); Battery Problem (2885)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 09/20/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A medical staff member prepared to transfer a patient from one hospital to another and damaged the rotaflow drive cable, therefore the patient was connected to another system.The battery of the new system went flat.Complaint# (b)(4).

Event Description

Complaint# (b)(4).

Manufacturer Narrative

The initial failure description was that the rotaflow battery went flat during patient transport.According to the provided service protocol from 2019-10-22 the device was tested and the device is free of safety or functional deficiencies.According to the provided information the battery was replaced before testing during the regular two year maintenance.The device was used for transport outside of the hospital which is outside of the intended use of the device.The reported transport took place between the (b)(6) hospital and the (b)(6) hospital.As the device is only intended to be used inside a hospital.Further the provided information suggests, that the device was not regularly charged ore maintained by the user, as the device was according to communication only used for training purposes.The most probable root cause for this issue is user error and that the device was not regularly maintained.According to rotaflow ifu (instructions for use | 3.3 | en | 10, page 10, chapter 2.1.4 intended environment) the rotaflow system is intended for use within clinical institutions.The rotaflow console is not designed for transport in an ambulance.Thus the failure could not be confirmed.The device was used for treatment when the reported event occurred.The reported event caused this complaint.The occurrence rate is below the acceptance rate, thus no remedial action 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: ROTAFLOW CENTRIFUGAL PUMP SYSTEM
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 9173845
• MDR Text Key: 199893720
• Report Number: 8010762-2019-00317
• 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: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCP00703163#RFC 20-970ROTAFLOW CONSOLE
• Device Catalogue Number: 70102.8707
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1