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

Model Number ROTAFLOW PUMP MODUL

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/10/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device will be investigated by a maquet field service technician.A supplemental medwatch will be submitted when additional information becomes available.(b)(4).

Event Description

It was reported that the bubble sensor on the rotaflow alarmed and stopped the pump.The pump showed a sig error-message for not having enough contact paste.The operator attempted to force paste in around the outlet after lifting the latch and it triggered the bubble-sensor.The user converted to hand-crank.The patient was without support for roughly 1 minute and when blood gases were taken they were at 90%.There was no reported harm to the patient.Another specialist came in to assist and quickly placed the disposable back in the drive and resumed support without incident.(b)(4).

Manufacturer Narrative

The problem experienced by the customer was the consequence of user error.The customer informed maquet that the operator had not followed the ifu.The maquet fse evaluated the unit and confirmed that there was no problem with the device.It was functioning as specified.It was confirmed by the customer that there was no patient injury or harm.

Event Description

(b)(4).

• Brand Name: ROTAFLOW CENTRIFUGAL PUMP SYSTEM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section G): BERND RAKOW; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt 76437 ; 4972229321
• MDR Report Key: 5405897
• MDR Text Key: 37747435
• Report Number: 8010762-2016-00058
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K991864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/16/2017

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: ROTAFLOW PUMP MODUL
• Device Catalogue Number: 701051712
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Initial Date Manufacturer Received: 01/11/2016
• Initial Date FDA Received: 02/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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: N
• Patient Sequence Number: 1