MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG QUADROX-ID OXYGENATOR

Model Number HMOD7000-USA

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2012

Event Type  Injury  

Event Description

The customer reported that the venous inlet had disconnected from the base of the oxygenator while flowing at 4lpm.The inlet was held in place while another circuit was prepared.The patient was stable during the entire process.Manufacturer previously submitted initial mfg.Report #(b)(4).

• Brand Name: QUADROX-ID OXYGENATOR
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 4365177
• MDR Text Key: 5232313
• Report Number: 3008355164-2014-00352
• 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: 12/16/2014,11/01/2012

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?: No
• Device Operator: Health Professional
• Device Model Number: HMOD7000-USA
• Device Catalogue Number: 70105.3325
• Device Lot Number: 70075647
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/01/2012
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/02/2012
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention