MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH MAQUET QUADROX-ID ADULT/ LIVA NOVA SMART PERFUSION PACK; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BEQ-HHMOD70000-USA

Device Problem Infusion or Flow Problem (2964)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/29/2022

Event Type  Injury  

Event Description

Ecmo circuit disruption leading to blood loss requiring treatment.Fda safety report id #:(b)(4).

Event Description

Ecmo circuit disruption leading to blood loss requiring treatment.Fda safety report id #:(b)(4).

• Brand Name: MAQUET QUADROX-ID ADULT/ LIVA NOVA SMART PERFUSION PACK
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH
• MDR Report Key: 13560784
• MDR Text Key: 285934946
• Report Number: MW5107559
• 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: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/15/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: BEQ-HHMOD70000-USA
• Device Lot Number: 3000189177/2031500056
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/17/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 32 YR
• Patient Sex: Female