MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG MCP00952291#ROTAFLOW DRIVE UNIT, BLUE

Catalog Number 70102.2161

Device Problem Improper Device Output (2953)

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

Event Date 03/10/2015

Event Type  malfunction  

Event Description

It was reported that the unit was not able to measure the flow.(b)(4).

Manufacturer Narrative

Maquet cardiopulmonary (b)(4) provides product failure investigation, analysis and resolution for the device described in this report.The device in question will be returned to maquet (b)(4) for investigation.A supplemental - medwatch will be submitted when additional information becomes available.

Manufacturer Narrative

The mfr evaluated the rotaflow drive (rfd) in question and it could be confirmed that no flow measurement is displayed.The device in question was sent to a supplier for further investigation and repair.The suppliers investigation confirmed that a lack of liability of the surface bonding of one ceramic led to the described failure.Based on the available info to the mfr at this time the reported failure could be confirmed.The cause was determined as a lack of liability of the surface bonding of one ceramic.The cause of the lack of liability of the individual ceramic can no longer be ascertained.The sensor body was replaced.The device was calibrated and successfully tested to specs.

Event Description

(b)(4).

• Brand Name: MCP00952291#ROTAFLOW DRIVE UNIT, BLUE
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer Contact: michael campbell ; kehler strasse 31; rastatt 76437 ; GM 76437 ; 2229321132
• MDR Report Key: 4787259
• MDR Text Key: 5855326
• Report Number: 8010762-2015-00466
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: K991864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,health professional,use
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 70102.2161
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/16/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1