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

Model Number ROTAFLOW DRIVE

Device Problems Bent (1059); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 08/16/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device will be evaluated by a maquet field service technician.A supplemental medwatch will be submitted if additional informations becomes available.

Event Description

According to the customer: it was reported that the rotaflow drive had bent pins which resulted in the error message "err_head".Additional information: the incident occurred before use, no patient was involved.(b)(4).

Manufacturer Narrative

(b)(4).The field service technician (fst) has been sent for further investigation.According to service order following works has been done: the fst detected that the control pcb became damaged.He replaced the defective control pcb with a new one.Furthermore, the field service technician checked the pump motor speed, the flow regulation and performed functional tests.He verifies that the rotaflow console meets factory specifications and checked interventions.The fst completes preventive maintenance with full calibration, functional testing and safety check to factory specification.The device is back for clinical use.Thus the failure could be confirmed.

Event Description

(b)(4).

• Brand Name: ROTAFLOW CENTRIFUGAL PUMP SYSTEM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): BERND RAKOW; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; GM
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; 4972229321
• MDR Report Key: 5939976
• MDR Text Key: 54761558
• Report Number: 8010762-2016-00557
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROTAFLOW DRIVE
• Device Catalogue Number: 70104.3292
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1