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

Model Number BEQ-HMOD 70000

Device Problems Air Leak (1008); Improper or Incorrect Procedure or Method (2017)

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

Event Date 12/31/2011

Event Type  Injury  

Event Description

It was reported that after four (4) days of patient use, the respiratory rn noticed a significant amount of air moving between the arterial side of the quadrox-id and their in-line arterial filter.They were able to clamp off and put the patient onto a new circuit with no issues.(b)(4).

• Brand Name: QUADROX-ID ADULT DIFFUSION MEMBRANE OXYGENATOR
• 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: 4365320
• MDR Text Key: 5259234
• Report Number: 3008355164-2014-00395
• Device Sequence Number: 1
• Product Code: DTZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/17/2014,01/02/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BEQ-HMOD 70000
• Device Catalogue Number: 70104.1193
• Device Lot Number: 70061613
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/02/2012
• Event Location: Hospital
• Date Report to Manufacturer: 01/04/2012
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/17/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 23 YR