MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG VKMO 31000-USA-QUADROX-I; QUADROX OXYGENATOR

Model Number VKMO 31000

Device Problem Filtration Problem (2941)

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

Event Date 02/10/2014

Event Type  Injury  

Event Description

(b)(4).

Manufacturer Narrative

(b)(4).Maquet cardiopulmonary (b)(4) provides product failure investigation, analysis and resolution for the device described in this report.A supplemental medwatch will be submitted if add'l info becomes available.(b)(4).

• Brand Name: VKMO 31000-USA-QUADROX-I
• Type of Device: QUADROX OXYGENATOR
• 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: 3812031
• MDR Text Key: 4398450
• Report Number: 8010762-2014-00191
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2014
• Device Model Number: VKMO 31000
• Device Catalogue Number: 70105.5116
• Device Lot Number: 70077962
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2012
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 3 YR
• Patient Weight: 14