MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HOLDERS FOR DISPOSABLES; HKHZ 19 CONVERSION KIT

Model Number HKHZ 19

Device Problems Failure To Adhere Or Bond (1031); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

According to the customer: "holder for oxygenator not tighten enough to stay in place." (b)(4).

Manufacturer Narrative

The product was not available for manufacturer's laboratory investigation.The failure is known to maquet cardiopulmonary and was investigated in a previous complaint.The most probable cause of the failure was determined as wear.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.

• Brand Name: HOLDERS FOR DISPOSABLES
• Type of Device: HKHZ 19 CONVERSION KIT
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer Contact: michael campbell ; kehler strasse 31; rastatt 76437 ; GM 76437 ; 2229321132
• MDR Report Key: 4874013
• MDR Text Key: 17302994
• Report Number: 8010762-2015-00756
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Type of Report: Initial
• Report Date: 06/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HKHZ 19
• Device Catalogue Number: 70104.7495
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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