FDA Adverse Event Malfunction Summary report: N

MAQUET HCU40 DEVICE

MDR report key: 5514773 · Received March 21, 2016

Report

Report Number: 8010762-2016-00202
Event Type: Malfunction
Date Received: March 21, 2016
Date of Event: February 25, 2016
Report Date: February 25, 2016
Manufacturer: MAQUET CARDIOPULMONARY AG
Product Code: DWC
PMA / PMN Number: K130300
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CH
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

(B)(6) 2016 03:25 PM (GMT-4:00) ADDED BY (B)(6) ((B)(4)): MAQUET MEDICAL SYSTEMS, USA SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET (B)(4). A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

Additional Manufacturer Narrative · 1

ON (B)(6) 2016 02:00 PM (GMT-4:00) ADDED BY (B)(6) ((B)(4)): A MAQUET FIELD SERVICE TECHNICIAN WAS ON SITE AND INVESTIGATED THE UNIT .THE TECHNICIAN TROUBLESHOT THE DEVICE AND FOUND A DEFECTIVE FLOW SENSOR ON THE CARDIOPLEGIA SIDE, WHICH WAS RESPONSIBLE FOR THE "WATER FLOW LOW" ERROR MESSAGE. THE FLOW SENSOR WAS EXCHANGED. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED IF ADDITIONAL INFORMATIONS BECOMES AVAILABLE.

Description of Event or Problem · 1

(B)(6) 2016 02:51 PM (GMT-4:00) ADDED BY (B)(6) ((B)(4)): IT WAS REPORTED THAT THE HCU40 DISPLAYED THE ERROR MESSAGE "WATER FLOW LOW" AT THE END OF DE-AIRING. THE INCIDENT OCCURRED DURING PRIMING / SETUP SO THERE WERE NO PATIENT INVOLVED. (B)(4).

Description of Event or Problem · 1

ON (B)(6) 2016 01:50 PM (GMT-4:00) ADDED BY (B)(6) ((B)(4)): (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
170185	MAQUET HCU40 DEVICE	CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS	DWC	MAQUET CARDIOPULMONARY AG	701044054

Patients

Seq	Age	Sex	Outcome	Treatment
1