MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG ROTAFLOW CENTRIFUGAL PUMP SYSTEM; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number MCP00967621#RFD

Device Problem Inaccurate Flow Rate (1249)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/13/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A supplemental medwatch will be submitted when additional information becomes available.

Event Description

It has been stated that there are large fluctuations in the flow rate display.Additional information: the issue has been detected during maintenance/service.No patient was involved.(b)(4).

Manufacturer Narrative

The device was investigated by em-tec.According to the service order (b)(4) the described problem could be not reproduced.But the closing assy was broken on delivery.A probable root cause could be the broken rfd closing, since the latter does not securely secure the pump head because of the material break.In addition and for preventive action em-tec replaced the rfd connection cable, because the cable is not sufficiently fixed on the connector side.The cable rotates in the strain relief.Hydraulic mast holder replaced (mast holder can no longer be tightened -- flat piston under the locking screw is missing, no oil in the holding arm).And the flow sensor has been replaced.Unit passed all functional and safety tests per factory specifications, returned to customer and cleared for clinical use.Thus the failure could be not confirmed.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time.Since the reported failure did not contribute to a death or serious injury no corrective action is needed.In addition at this time it cannot be concluded that this is a systemic error.A supplemental medwatch will be submitted if additional informations becomes available.

Event Description

(b)(4).

• Brand Name: ROTAFLOW CENTRIFUGAL PUMP SYSTEM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): BERND RAKOW; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; GM
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; 4972229321
• MDR Report Key: 5966299
• MDR Text Key: 55669943
• Report Number: 8010762-2016-00581
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCP00967621#RFD
• Device Catalogue Number: 701010875
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2016
• Date Device Manufactured: 12/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1