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

Model Number ROTAFLOW CONSOLE

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/26/2017

Event Type  malfunction  

Manufacturer Narrative

The device in question was in the repair depot for service/maintenance.According to the service order unit was operational when testing began.During testing unit alarmed "error offset" and became non-functional.Detected defective flow measurement board.The flow measurement board has been replaced.Calibration check, full functional test and safety check as per service manual.All tests passed.Thus the failure could be confirmed.Since the reported failure did not contribute to a death or serious injury no corrective action is needed.In addition at this time it cannot be concluded that this is a systemic error.No corrective action is needed.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time.

Event Description

It was reported that the rotaflow was operational when testing began.During testing unit alarmed "error offset" and became non-functional.The incident occurred in the service depot during service/maintenance.No patient was involved.(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: 6701433
• MDR Text Key: 79811921
• Report Number: 8010762-2017-00215
• 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: consumer,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROTAFLOW CONSOLE
• Device Catalogue Number: 701043292
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/26/2017
• Initial Date FDA Received: 07/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1