MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG MAQUET HUC30 DEVICE; HCU 30 BASE UNIT 200-240 V

Model Number 70102.8718

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/29/2015

Event Type  Injury  

Event Description

It was reported that during ecmo therapy, the unit was leaking water from the patient sie systemic hose.The customer removed the hose and replaced with a backup hose.The unit was then replaced with another unit.No reported patient effect.Ecmo- extra corporeal membrane oxygenation.(b)(4).

• Brand Name: MAQUET HUC30 DEVICE
• Type of Device: HCU 30 BASE UNIT 200-240 V
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): MAQUET MEDICAL SYSTEMS USA; 45 barbour pond drive; wayne NJ 07470 000
• Manufacturer Contact: 45 barbour pond drive; wayne, NJ 07470-0000
• MDR Report Key: 4559174
• MDR Text Key: 5548129
• Report Number: 3008355164-2015-00030
• Device Sequence Number: 1
• Product Code: DWC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/26/2015,01/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70102.8718
• Device Catalogue Number: 70102.8718
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/30/2015
• Device Age: 10 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/30/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention