MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG QUADROX-1 ADULT

Model Number HMOD 70000

Device Problem Occlusion Within Device (1423)

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

Event Date 01/23/2013

Event Type  Injury  

Event Description

The customer stated that he had changed out one hmod70000 on (b)(6) 2012 due to clotting within 10 hours of initial deployment.According to the customer, this clotting behavior is not what they ordinarily observe when using quadrox id.The customer stated that no temperature probe was used and that the delta pressure was 85 at the time of change out.The pt was a neonate, veno-venous, with all coagulation profiles with nch protocols.The customer noted that they used an adult quadrox id as they had experienced clotting issues with the pediatric quadrox id.(b)(4).

• Brand Name: QUADROX-1 ADULT
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 4365259
• MDR Text Key: 5266953
• Report Number: 3008355164-2014-00335
• 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: 12/15/2014,01/31/2013

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
• Device Model Number: HMOD 70000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/23/2013
• Event Location: Hospital
• Date Report to Manufacturer: 02/01/2012
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention