MAUDE Adverse Event Report: MAQUET CARDIOPULMOARY AG QUADROX-I PED. DIFFUSION MEMBRANE OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BY-PASS

Model Number 70105.0330

Device Problem Decrease in Pressure (1490)

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

Event Date 10/29/2011

Event Type  Injury  

Event Description

On (b)(6) 2011, at (b)(6) medical center, an issue occurred with quadrox-i pediatric diffusion membrane oxygenator (lot number unknown).According to the customer, a strange event occurred when the patient in the nicu was about to be clamped off.The pre-membrane pressure was reading 170 at the beginning of the nurse shift; within 2 hours the pressure was reading -90's and later on the reading was -200's.There was no visible clotting noted.The transducer was changed and fluids were halted; however, no difference in the pressure.The arterial pressure was normal and the vrm was 20's.No back pressure when sampling from the ports when the pressure difference was in the -90's.The circuit was replaced.The customer reported that a similar event occurred with the replacement circuit.The customer also noted that there were diffuse pinpoint white dots from the bladder to the rotaflow head.No visible clots in the membrane.A separate medwatch will be submitted for the first event with the first device.Reference mfr report # 8010762-2014-01120.(b)(4).

Manufacturer Narrative

(b)(4).The sample was not return for analysis.(b)(4).

• Brand Name: QUADROX-I PED. DIFFUSION MEMBRANE OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BY-PASS
• Manufacturer (Section D): MAQUET CARDIOPULMOARY AG; kehler strasse 31; rastatt, 7643 7; GM 76437
• Manufacturer (Section G): MAQUET CARDIOPULMOARY AG; kehler strasse 31; rastatt, 7643 7; GM 76437
• Manufacturer Contact: tina evancho ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097265
• MDR Report Key: 4283041
• MDR Text Key: 5298659
• Report Number: 8010762-2014-01226
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/01/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70105.0330
• Device Catalogue Number: BEQ-HMOD 30000-USA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/01/2011
• Event Location: Hospital
• Date Report to Manufacturer: 11/01/2011
• Date Manufacturer Received: 11/01/2011
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention