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

Model Number 701022161 - ROTAFLOW DRIVE UNIT, BLUE

Device Problem Failure to Pump (1502)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/09/2019

Event Type  malfunction  

Manufacturer Narrative

A follow up medwatch will be submitted when additional information becomes available.

Event Description

The customer reported the rotaflow drive on the hl30 stopped during perfusion.After the rotaflow was manual restarted, they were able to finish the perfusion.(b)(4).

Manufacturer Narrative

The initial failure description was "head error".Since there will be no repair and the device is out of use, no further investigation could be performed.Therefore no most probable root cause could be determined.Thus the reported failure "head error" could not be confirmed.The reported failure happened during treatment.The rotaflow drive which was used, was responsible for this complaint.The occurence rate regarding the above complaint is below the acceptance rate.Thus, no remedial action required.The ocurrence rate related to the reported issue is currently being monitored as part of maquet cardiopumonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.

Event Description

Complaint# (b)(4).

• Brand Name: ROTAFLOW CENTRIFUGAL PUMP SYSTEM
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 9114716
• MDR Text Key: 192161677
• Report Number: 8010762-2019-00299
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• PMA/PMN Number: K991864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 701022161 - ROTAFLOW DRIVE UNIT, BLUE
• Device Catalogue Number: 701022096
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1