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

Model Number 701022161

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 05/06/2019

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 the rotaflow showed a "head error" above 1500 rpm.A harm or serious injury to a patient was not reported.A head error can lead to a pump stop.(b)(4).

Event Description

It was reported that the rotaflow showed a "head error" above 1500 rpm.A harm or serious injury to a patient was not reported.A head error can lead to a pump stop.Complaint one track#: (b)(4).

Manufacturer Narrative

The device in question has been sent to the manufacturer em-tec (germany) for repair.According to the em-tec service report rma2019-10146, dated on 2019-07-11, the technician could confirm the reported failure and replaced the defective ild.After the repair the rotaflow drive passed all tests.(see maquet-service order#: 10477599, dated on 2019-07-18).The most probable root cause could be determined as a "hot-plug" due to mishandling.Thus the failure could be confirmed.In the course of the investigation of nc-17-06-011 all complaints were analyzed individually to look for patterns and causes.After evaluation of the complaints, the following defects are the most common: hot plug, sig error followed by head error, error message due to shaking / error message due to sensitivity, connection problems and hardware-error.The increase in complaints with the error "head error" is due to a user / application error.The actions have been addressed in the past to prevent application errors.Furthermore, the instructions for use of the rotaflow system, see rotaflow system user manual, mcv-ga-10000703-de-11, contain detailed descriptions to prevent an "error head".In addition, the instruction manual describes how the user has to react in case of an error message so that the application can be continued if possible.Since there are several causes of errors that result in an error head (error head) message, no final root cause could be determined.It is noticeable that the evaluated error is largely due to a user error.Warning in the ifu regarding "hotplug" and label with the "hotplug" warning on the rfc have already been implemented in the past.

• 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: 8645371
• MDR Text Key: 146246298
• Report Number: 8010762-2019-00142
• 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: 08/28/2019

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: 701022161
• Device Catalogue Number: 701022161
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/07/2019
• Initial Date FDA Received: 05/28/2019
• Supplement Dates Manufacturer Received: 05/07/2019
• Supplement Dates FDA Received: 09/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention