MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG ROTAFLOW CENTRIFUGAL PUMP SYSTEM

Model Number MCP00703177

Device Problem Measurement System Incompatibility (2982)

Patient Problem No Patient Involvement (2645)

Event Date 06/01/2015

Event Type  malfunction  

Event Description

It was reported that the flow measurement is out of threshold of tolerance.The deviation goes from 10% to 30% in some cases.(b)(4).(b)(4).

Manufacturer Narrative

Maquet cardiopulmonary ag provide failure investigation, analysis and resolution for the device described in this report.The device in question has arrived at maquet (b)(4) but the investigation is still pending.A supplemental - medwatch will be submitted when additional information becomes available.

Manufacturer Narrative

The mfr received the product in question for evaluation.A broken closing assy was found.Due to the defect on the product, the necessary tests were not possible to be performed.Therefore the device had to be sent to a supplier for repair as well as further testing and calibration.During the suppliers investigation the reported failure "flow measurement out of threshold of tolerance" could be confirmed.It was caused by liquid, that was found within the flow-sensor, that also led to the loss of adherence of the ceramics.The source for the liquid is unknown.The flow-sensor was replaced.In addition the iron ring of the "magnet-coupling" was found to be loosened due to a drop/fall of the drive.The iron ring of the "magnet-coupling" was refastened and as a precaution both bearings were replaced.The broken closing assy was also replaced.The device was tested and recalibrated and meets all mfrs specifications.Based on the information available to the mfr at this time the reported failure "flow measurement ou of threshold of tolerance" could be confirmed and was caused by liquid within the flow- sensor.However, the source of the liquid could not be determined.

Event Description

(b)(4).

• Brand Name: ROTAFLOW CENTRIFUGAL PUMP SYSTEM
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer Contact: michael campbell ; kehler strasse 31; rastatt 76437 ; GM 76437 ; 2229321132
• MDR Report Key: 4868065
• MDR Text Key: 6059491
• Report Number: 8010762-2015-00753
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K991864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,foreign,health pr
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCP00703177
• Device Catalogue Number: 70102.8711
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/16/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2015
• Date Device Manufactured: 04/01/2009
• 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