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

Model Number 70105,1712

Device Problems Device Displays Incorrect Message (2591); Pressure Problem (3012)

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

Event Date 08/27/2013

Event Type  Injury  

Event Description

On (b)(6) 2013, at the (b)(6) a rotaflow console (serial number (b)(4)) and rotaflow drive (not known) was being set up and primed as routine.Seventeen (17) minutes into the pump run, the rotaflow started to alarm and there were dash marks in the lpm screen, however, the rpms were between 3300-3400.The volume and pressures were acceptable so there was flow.The tubing came off the pump, contact cream was reapplied and the tubing went back on the pump.The lpm still would not read but had flow.A back up rotaflow console was placed into the room.The drive line was swapped out into a new console.It is unclear if the pump was turned off during the drive line change.When the console was turned back on, still no lpms but there was a rpm readout.A replacement drive was obtained and used on the second console.Once this swapped occurred the rpm and lpm were present and the unit went back on bypass.Hand cranking was performed for 30 seconds to a minute when these activities were performed.No effects to the patient.Reference complaint (b)(4).

Manufacturer Narrative

(b)(4).The console was evaluated by a ssu technician and the flow measurement board was replaced.The device was tested to factory specifications and passed all tests.Reference complaint (b)(4).

• Brand Name: ROTAFLOW CENTRIFUGAL PUMP SYSTEM
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• 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: 4931720
• MDR Text Key: 6028782
• Report Number: 8010762-2014-00910
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K991864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/28/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70105,1712
• Device Catalogue Number: 70105,1712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/28/2013
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/28/2013
• Initial Date Manufacturer Received: 08/28/2013
• Initial Date FDA Received: 07/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2012
• 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