MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH ROTAFLOW CENTRIFUGAL PUMP SYSTEM; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 701046412 - ROTAFLOW EN/NORTH AM US-PLUG

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

A follow-up medwatch will be submitted whn addtional information becomes available.

Event Description

Complaint# (b)(4).During patient treatment: rotaflow drive showed a runaway error.

Manufacturer Narrative

The rotaflow drive was investigated with the service order report# (b)(4) from the maquet service technician on the 2019-12-02: the occurence rate regarding the above complaint is below the acceptance rate.Thus, no remedial action required.Customer stated that the system displayed a "runaway "on screen during use.As a precaution the system was removed and a backup was used.Service observed the rotaflow drive and cleaned the system from and abundance of dust.Tested system for 2 plus hours with no incident.Unit passed all calibration, functional and safety tests performed.Unit was returned to customer and cleared for clinical use.The failure could not be confirmed therefore no probable root cause.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopumonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.

Event Description

During patient treatment a "runaway error" occurred.(b)(4).

• Brand Name: ROTAFLOW CENTRIFUGAL PUMP SYSTEM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 9466846
• MDR Text Key: 204204640
• Report Number: 8010762-2019-00391
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K991864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 701046412 - ROTAFLOW EN/NORTH AM US-PLUG
• Device Catalogue Number: MCP0.0952292
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Date Manufacturer Received: 12/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1