MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG 70000#QUADROX-I HMO 70000+VHK 2001; OXYGENATOR + VENOUS HARDCOVER RESERVOIR

Model Number VKMO 7000

Device Problems Inadequate Filtration Process (2308); Filtration Problem (2941)

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

Event Date 02/05/2014

Event Type  Other  

Event Description

This product was being used in an emergency dissection case.After applying it for 2 hours, air occurred in reservoir.(b)(4).

Manufacturer Narrative

(b)(4).A supplemental medwatch will be submitted if add'l info becomes available.

• Brand Name: 70000#QUADROX-I HMO 70000+VHK 2001
• Type of Device: OXYGENATOR + VENOUS HARDCOVER RESERVOIR
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): MAQUET CARDIOPULMONARY AG; kehler strasse 31; rastatt 7643 7; GM 76437
• Manufacturer Contact: janice pevide ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097753
• MDR Report Key: 3688177
• MDR Text Key: 4300713
• Report Number: 8010762-2014-00130
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K082117
• 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
• Type of Report: Initial
• Report Date: 03/11/2014,02/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2015
• Device Model Number: VKMO 7000
• Device Catalogue Number: 70103.2230
• Device Lot Number: 70092936
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/20/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/10/2014
• Device Age: 7 MO
• Event Location: Hospital
• Date Manufacturer Received: 02/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2013
• 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