MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG ROTAFLOW CENTRIFUGAL PUMP SYSTEM; PUMP, BLOOD, CARDIOPULMONARY BYPASS

Model Number 70101.0875

Device Problems No Display/Image (1183); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 09/21/2011

Event Type  malfunction  

Event Description

On (b)(6) 2011 at the (b)(6) hospital in (b)(6), it was reported that during setup for a procedure with the rotaflow drive unit (rfd) serial number (b)(4) when the flow control knob was turned there was no display of flow or rotations per minute (rpm).The rfd was also not operational and was removed from service.When the rfd was used with a different rotaflow console, the above reported symptom was reproduced.There was no patient involvement.(b)(4).

Manufacturer Narrative

(b)(4).Per service report (b)(4) completed on (b)(4) 2012 the motor control boards mc1, mc2 and the magnetic coupling were replaced.Functional testing and safety check to factory specifications was performed and the device passed all tests.(b)(4).

• Brand Name: ROTAFLOW CENTRIFUGAL PUMP SYSTEM
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; kehler strasse 31; rastatt, 7643 7; GM 76437
• Manufacturer (Section G): MAQUET CARDIOPULMONARY AG; kehler strasse 31; rastatt, 7643 7; GM 76437
• Manufacturer Contact: tina evancho ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097265
• MDR Report Key: 4285732
• MDR Text Key: 5059459
• Report Number: 8010762-2014-01044
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/27/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70101.0875
• Device Catalogue Number: 70101.0875
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 09/27/2011
• Initial Date Manufacturer Received: 09/27/2011
• Initial Date FDA Received: 12/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2008
• 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