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

Model Number ROTAFLOW

Device Problems No Audible Alarm (1019); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/14/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).Device evaluated by mfr: device not returned, not evaluated.

Event Description

During patient treatment the pump did not work without an error message.No harm to the patient was reported.Complaint# (b)(4).

Manufacturer Narrative

The rotaflow drive was investigated from emtec service technician with the service order report# rma2019-10139 and order# 300366878 on the 2019-04-05: the described failure of the customer could be confirmed.The speedometer disc broke due to touching or grinding the hedl (end coding module), but the speedometer disc was not loose on the shaft.Therefore the speedometer was exchanged.Root cause unknown.The device was also investigated from the getinge service technician with the service order report# 10477609 and customer order# :rma# 38319 on the 2019-06-28: problem description: defective tacho strobe was exchanged.Rotaflow has passed all tests see also the service protocol.

Event Description

Complaint# (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: 8645423
• MDR Text Key: 146376416
• Report Number: 8010762-2019-00145
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROTAFLOW
• Device Catalogue Number: 701022161
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention