FDA Adverse Event Malfunction Summary report: N

ROTAFLOW CENTRIFUGAL PUMP SYSTEM

MDR report key: 5289862 · Received December 11, 2015

Report

Report Number: 8010762-2015-01230
Event Type: Malfunction
Date Received: December 11, 2015
Date of Event: November 17, 2015
Report Date: November 19, 2015
Manufacturer: MAQUET CARDIOPULMONARY AG
Product Code: DTQ
PMA / PMN Number: K991864
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CH
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

ON (B)(6) 2015 12:36 PM (GMT-5:00) ADDED BY (B)(6) ((B)(4)): (B)(4). THE DEVICE IN QUESTION WAS EVALUATED BY A MAQUET FIELD SERVICE TECHNICIAN. THE RFD WAS CHECKED AND NO VISUAL DAMAGE WAS CONFIRMED. THE MANUFACTURER HAS REQUESTED THE DEVICE FOR FURTHER EVALUATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Additional Manufacturer Narrative · 1

(B)(5). THE DEVICE WAS EVALUATED BY A MAQUET SERVICE TECHNICIAN. THE REPORTED FAILURE "HANDLE CANNOT BE TURNED" WAS CONFIRMED. AS THE ROOT CAUSE IT WAS FOUND THAT IN BETWEEN THE GEAR AND THE HOUSING A SCREW WAS STUCK. THIS SCREW HAD LOOSENED FROM THE FIXATION POINT ON THE BOARD. THE GEAR WAS DAMAGED ON THE FLANKS BY THE SCREW. A NEW GEAR WAS ORDERED. AFTER THE REPLACEMENT OF THE DAMAGED GEAR THE DEVICE WILL BE RETURNED.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING AN TRAINING TRY TO RUNNING THE ROTAFLOW EMERGENCY DRIVE(RFE) FOR SIMULATION, THE RFE STARTED TURNING NOT SMOOTH AND SUDDENLY COULDN`T BE TURNED ANYMORE. (B)(4).

Description of Event or Problem · 1

(B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
819036	ROTAFLOW CENTRIFUGAL PUMP SYSTEM	CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS	DTQ	MAQUET CARDIOPULMONARY AG	ROTAFLOW CONSOLE

Patients

Seq	Age	Sex	Outcome	Treatment
1