MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG OXYGENATOR, CARDIOPULMONARY BYPASS; DTZ

Model Number 70104.8759

Device Problem Material Deformation (2976)

Patient Problem Not Applicable (3189)

Event Date 08/10/2015

Event Type  malfunction  

Manufacturer Narrative

The product was investigated under complaint (b)(4) in the laboratory of the manufacturer.During visual inspection of the product a crack in the recirculation line connector was detected.This additional complaint was opened in order to cover the failure.No evidence was provided that this failure was noticed within the initial complaint report.The manufacturer's review of the quality control process indicated that a 100% functional inspection for leakage is conducted during manufacturing.The information obtained so far in this investigation would confirm that the device met its specification at the time of manufacturing and therefore all damages found on the product are due to excessive or inadequate external physical force that was exerted on the product after the release.The exact root-cause which led to the described failure could not be identified.This data will be handled through a designated maquet trending process.If a trend occurs, it will be escalated to quality assurance management for review and determination if further investigation is necessary.Due to this no further action will be completed at this time.

Event Description

During investigation of a complaint, an additional malfunction was found in the laboratory of the manufacturer.During visual inspection of the product a damaged blood outlet connector was detected.(b)(4).

• Brand Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Type of Device: DTZ
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer Contact: michael campbell ; kehler strabe 31; rastatt 76437 ; GM 76437 ; 2229321132
• MDR Report Key: 5008671
• MDR Text Key: 23519617
• Report Number: 8010762-2015-00887
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K082117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Not Applicable
• Report Date: 08/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/01/2016
• Device Model Number: 70104.8759
• Device Catalogue Number: HMO 70000-J
• Device Lot Number: 70101041
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/17/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2014
• 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