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

Model Number MCP00706035#ROTAFLO

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 02/12/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).

Event Description

(b)(4).It was reported a head error occurred.A patient involvement was not reported.

Event Description

Internal reference: (b)(4).Customer reference: (b)(4).

Manufacturer Narrative

Data corrected in section d.A rotaflow drive with article number 701022161 and serial number (b)(6) was provided in the initial report but this was made by mistake.The correct device is provided in section d now.A getinge field service technician was on side to check the device in question.After conversation with the ssu on 2019-09-11 the rotaflow console with s/n (b)(4) was not affected.The reason being the initial service request called in by the customer was for the s/n of the console.Once the issue was determined to be the drive head the second complaint (b)(4) was created rotaflow console has no problem therefore no work has performed on this device.Thus the failure could not be confirmed.Most probable root cause could not be determined, because no failure was detected.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.

• 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: 8371160
• MDR Text Key: 139595034
• Report Number: 8010762-2019-00050
• 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: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCP00706035#ROTAFLO
• Device Catalogue Number: 701043292
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1