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

Model Number 701051713 - ROTAFLOW EN/NORTH AM US-PLUG ICU

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 when additional information becomes available.Device not returned not eval.

Event Description

Rotaflow error head.Complaint# (b)(4).

Event Description

During power up a " head error" appeared on the display of the rotaflow.No patient involvement.(b)(4).

Manufacturer Narrative

The occurence rate regarding the above complaint is below the acceptance rate.Thus no remedial action required.The rotaflow drive was investigated with the service order report# (b)(4) from the maquet service technician on the 2019-12-09: the customer cancelled the service request.This unit has been retired from service due to cost of repairs.Because of no investigation there is no most probable root cause possible.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.H3 other text : the customer doesn't want to check the device.

• 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: 8939989
• MDR Text Key: 182552740
• Report Number: 8010762-2019-00270
• 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: 08/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 701051713 - ROTAFLOW EN/NORTH AM US-PLUG ICU
• Device Catalogue Number: 70105.1512
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1