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

Model Number MCP00706291#ROTAFLOW CHINESE ZH-PLUG

Device Problems Device Displays Incorrect Message (2591); Appropriate Term/Code Not Available (3191)

Patient Problems No Patient Involvement (2645); No Code Available (3191)

Event Date 05/04/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).

Event Description

It was reported that the customer found a rotaflow equipment failure before use, when the device speed is above 1700, alarm: err head occurred.This error can lead to a pump stop.No patient involved.(b)(4).

Event Description

Complaint onetrack# (b)(4).

Manufacturer Narrative

The investigation results to this reported event were already submitted under the mfg report number 8010762-2019-00187, during the investigation of the complaint (b)(4).The reported incident was submitted twice to the dcu.As all information was already submitted, no further information will be submitted with this emdr.The occurence rate is below the acceptance rate, thus no remedial action required the occurrence 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.

• Brand Name: ROTAFLOW CENTRIFUGAL PUMP SYSTEM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET GMBH; kehler strasse 31; rastatt
• MDR Report Key: 8645508
• MDR Text Key: 146239608
• Report Number: 8010762-2019-00144
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 12/18/2019

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: MCP00706291#ROTAFLOW CHINESE ZH-PLUG
• Device Catalogue Number: 70104.6405
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/05/2019
• Initial Date FDA Received: 05/28/2019
• Supplement Dates Manufacturer Received: 10/09/2019
• Supplement Dates FDA Received: 12/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1