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

Model Number 701022162

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 05/07/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).Device not returned.

Event Description

It was reported that during preventive maintenance the message "error head" occurred.The technician was not sure if the console or the drive was the issue.A patient was not involved.Complaint onetrack# (b)(4).

Manufacturer Narrative

The initial failure description was "rotaflow head error".According to the service order report#: (b)(4) (dated on (b)(6) 2019), the technician was on site and found out that the problem is with the rotaflow console.Due to this the technician replaced the power supply and rotaflow drive connection cable.The unit operated 48 hours without issue.The unit passed all functional and safety tests as per the service manual.This work was performed on (b)(6) 2019 (see service order#: (b)(6).Due to the fact that the technician replaced the connection cable the most probable root cause could be determined as follows: the head error can be caused by connection issues between the console (rfc) and the drive (rfd).This is when the cable connection is disturbed by defective pins.Furthermore, the instructions for use of the rotaflow system, see rotaflow system user manuel, mcv-ga-10000703-de-11, chapter 8.1.2 detailed descriptions to prevent an ¿error head¿.Therefore the reported failure could be confirmed.The device was not being used for treatment and diagnosis.The event occurred during preventive maintenance.Due to the fact that maquet is the manufacturer of the rotaflow there is a relationship between the device and the complaint.The occurence rate regarding the above complaint is below the acceptance rate.Thus, no remedial action required.The ocurrance 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 one track#: (b)(4).

• Brand Name: ROTAFLOW CENTRIFUGAL PUMP SYSTEM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 8665901
• MDR Text Key: 146948867
• Report Number: 8010762-2019-00157
• 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,user faci
• Type of Report: Initial,Followup
• Report Date: 12/04/2019

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: 701022162
• Device Catalogue Number: 701022161
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/07/2019
• Initial Date FDA Received: 06/04/2019
• Supplement Dates Manufacturer Received: 12/04/2019
• Supplement Dates FDA Received: 12/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention