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

Model Number ROTAFLOW CONSOLE

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 04/16/2018

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).During patient on ecls with rotaflow the ultrasonic paste was reapplied then a "head error" occurred with pump stop.The medical staff did handcrank before the patient was connected to a new device.No harm to the patient was reported.

Manufacturer Narrative

Maquet medical systems,usa(importer)submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).Rastatt, germany.A follow-up medwatch will be submitted when additional information becomes available.Reference exemption #(b)(4).Importer- maquet medical systems usa (b)(4).Contact person- (b)(6).The device was investigated with the summery report# (b)(4).By a getinge service technician: a complete system checkout was performed.Seated and reseated head unit.The head plug in rear of the machine for loose fitting was checked.Unseated and reseated boards inside the unit.The washer for e drive tensioner was replaced.The error was not reproducible.Checks safe to operate.Released to customer for clinical use.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

Internal reference: (b)(4).Autonumber:(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
• MDR Report Key: 7443601
• MDR Text Key: 106248657
• Report Number: 8010762-2018-00144
• 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
• Type of Report: Initial,Followup
• Report Date: 05/24/2018

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
• Initial Date Manufacturer Received: 04/16/2018
• Initial Date FDA Received: 04/19/2018
• Supplement Dates Manufacturer Received: 04/16/2018
• Supplement Dates FDA Received: 05/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1