MAUDE Adverse Event Report: MAQUET CARDIOPLMONARY AG QUADROX-ID PAD.O.FILT

Model Number 70105.0330

Device Problem Pressure Problem (3012)

Patient Problems Death (1802); Hemolysis (1886); Hemorrhage/Bleeding (1888)

Event Date 04/28/2015

Event Type  Death  

Event Description

It was reported that a potential problem with high pressures developing shortly into the use of the device (within 24 hours) were noticed.The pressure drop increased.No additional patient effects or specifics have been reported.The product was replaced during treatment.Multiple units have been used on this one patient.Pediatric units have been swapped out for an adult capacity unit.Additional information received 06/23/2015: the first membrane was replaced on the (b)(6) at 10pm.The trans-membrane pressure increased from approx 50 (4/27, 10am) to 100 (4/28, 6pm).The post-membrane pressure was stable at -120 mm hg throughout.The pre-membrane increased from -170 to -245 blood flow approximately.85lpm; gas flow approximately 3lpm 5+ days of use.No patient effect is attributed to the changes of devices.Support was withdrawn at the families request after 48 days of ecmo.The lungs were not recovering/healing.(b)(4).

• Brand Name: QUADROX-ID PAD.O.FILT
• Manufacturer (Section D): MAQUET CARDIOPLMONARY 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: 4871812
• MDR Text Key: 6061973
• Report Number: 3008355164-2015-00132
• 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: 06/25/2015,05/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2016
• Device Model Number: 70105.0330
• Device Catalogue Number: BEQ-HMOD30000
• Device Lot Number: 70102111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/26/2015
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/26/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention