MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HEART LUNG MACHINE; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number ROTAFLOW

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/15/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the rotaflow consolae surfaced a sig error message multiple times while on a patient regardless of conductive paste application.No harm to person was reported.Complaint number: (b)(4).

Event Description

Complaint number: (b)(4).

Manufacturer Narrative

A sig error message multiple times while on patient was reported.According to the summary report 43486433 (dated on 2020-10-14/16) the unit will be repaired in the depot under ra number 6931008604.Under service order report 43491206 the rotaflow console was tested and passed all tests after the drive was replaced.This work was performed on 2020-10-20/21.The defect rotaflow drive was send back to germany for report under rma#42471.According to the service order rma2020-10382 dated on 2020-12-11 the flow senor has been replaced.The rotaflow drive was tested and passed all tests.Based on this the failure could be confirmed.Most possible root cause could be determined as: aging the occurrence rate was calculated for the reported issue and it was determined that this is not a systemic issue.Therefore, no remedial action is required the occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.

• Brand Name: HEART LUNG MACHINE
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 10695775
• MDR Text Key: 211927316
• Report Number: 8010762-2020-00347
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• PMA/PMN Number: K090515
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROTAFLOW
• Device Catalogue Number: 70105.1712
• Date Manufacturer Received: 12/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1