MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG QUADROX-I; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number 70103.1736

Device Problems Fluid/Blood Leak (1250); Fracture (1260); Leak/Splash (1354)

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

Event Date 09/23/2014

Event Type  malfunction  

Event Description

It was reported that during priming the device was observed to exhibit leakage at the blood outlet.It appeared to be a hairline fracture.The oxygenator was part of following tubing set: hqv 6718#hl 30 - membranset.Model # 70104.1611, lot#: 92118244.(b)(4).

Manufacturer Narrative

Maquet cardiopulmonary (b)(4) has not yet received the device back for investigation.A supplemental medwatch will be sent when add'l info becomes available.

• Brand Name: QUADROX-I
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer Contact: michael campbell ; kehler strasse 31; rastatt 76437 ; GM 76437 ; 2229321132
• MDR Report Key: 4209001
• MDR Text Key: 18291978
• Report Number: 8010762-2014-00812
• Device Sequence Number: 1
• Product Code: DTM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K132829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2015
• Device Catalogue Number: 70103.1736
• Device Lot Number: 70094643
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2013
• 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
• Patient Weight: 4