MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG QUADROX-I; DTZ

Model Number HMO70000-USA

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Patient Involvement (2645)

Event Type  Injury  

Event Description

The customer stated that "they observed the 3/8 inch arterial port of a hmo70000 come out when being used in a wet lab a couple of months ago.It appeared to un-glue".There are no further details known.No sample is available.No patient involvement.(b)(4).

• Brand Name: QUADROX-I
• Type of Device: DTZ
• 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: 4365350
• MDR Text Key: 15329636
• Report Number: 3008355164-2014-00359
• 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: 12/16/2014,05/23/2012

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?: Yes
• Device Operator: Health Professional
• Device Model Number: HMO70000-USA
• Device Catalogue Number: 70104.5574
• Device Lot Number: 70058648
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/23/2012
• Event Location: Hospital
• Date Report to Manufacturer: 05/23/2012
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention