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

Model Number BEQ-HMOD70000-USA

Device Problems Partial Blockage (1065); Occlusion Within Device (1423)

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

Event Date 04/10/2015

Event Type  Injury  

Event Description

It was reported that elective rvad-ecmo had been initiated and a quadrox device appeared to have an obstruction to forward blood flow.The pressure drop in the membrane was 375 mmhg at 1.5 to 2 l/min flow.The device was exchanged.The patient did incur period of at least 15 minutes of inadequate unloading of the rv.The 2nd device performed satisfactorily.Additional information obtained- blood flow: 1-2 l/min, pre-oxy membrane pressure: 425 mmhg, post-oxy membrane pressure: 58 mmhg.Rvad-ecmo right ventricular assist device extracorporeal membrane oxygenation.Rv-right ventricle.(b)(4).

Event Description

(b)(4).

Event Description

(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: 4763080
• MDR Text Key: 5786106
• Report Number: 3008355164-2015-00092
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/08/2015,04/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BEQ-HMOD70000-USA
• Device Catalogue Number: 70105.3824
• Device Lot Number: 70103046
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/10/2015
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention