MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG QUADROX-ID PEDIATRIC HMO 31000

Device Problem Device Alarm System (1012)

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

Event Date 07/23/2013

Event Type  Injury  

Event Description

(b)(6) perfusionist at the b)(6) state during pediatric case, the bubble detector alarmed detecting a bubble in the arterial line.He said they had to terminate bypass and disconnect the arterial cannula and push the air out.They resumed bypass and finished the case without incident.(b)(4).

• Brand Name: QUADROX-ID PEDIATRIC HMO 31000
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 4365181
• MDR Text Key: 5232315
• Report Number: 3008355164-2014-00314
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/12/2014,07/23/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/23/2013
• Date Report to Manufacturer: 12/12/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention