MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG 01971100#QUADROX-I; MICROPOROUS MEMBRANE OXYGENATOR

Model Number 70103.1733

Device Problems Increase in Pressure (1491); Pressure Problem (3012)

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

Event Date 02/12/2014

Event Type  malfunction  

Event Description

It was reported that after five min bypass, the pressure increased rapidly in the oxygenator.The pt was well anticoagulated, with an act at 565 sec and with 2,5 l/flow they have a pressure at 500mmhg.They hadn't clamped the aorta so they weaned the pt from bypass and changed system.Ref.: (b)(4).

Manufacturer Narrative

(b)(4).Maquet cardiopulmonary (b)(4) provides product failure investigation, analysis and corrective actions for the device described in this report.The mfr has not rec'd the device for investigation.A request to obtain the device was issued.Once the device became available, the investigation will begin to determine the root-cause.A supplemental medwatch will be submitted as soon as further info becomes available.

• Brand Name: 01971100#QUADROX-I
• Type of Device: MICROPOROUS MEMBRANE OXYGENATOR
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): MAQUET CARDIOPULMONARY AG; kehler strasse 31; rastatt 76437 ; GM 76437
• Manufacturer Contact: janice pevide ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097753
• MDR Report Key: 3727132
• MDR Text Key: 16059293
• Report Number: 8010762-2014-00100
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K101153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/27/2014,02/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2014
• Device Model Number: 70103.1733
• Device Catalogue Number: 01971100#QUADROX-I
• Device Lot Number: 70095255
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/27/2014
• Device Age: 8 MO
• Event Location: Hospital
• Date Manufacturer Received: 02/14/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2013
• 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