• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MAQUET CARDIOPULMONARY GMBH HEART LUNG MACHINE; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE Back to Search Results
Model Number ROTAFLOW
Device Problem Electrical /Electronic Property Problem (1198)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/28/2021
Event Type  malfunction  
Manufacturer Narrative
A follow-up medwatch will be submitted when additional information becomes available.
 
Event Description
The rotaflow displays the error message "head error" during patient treatment.The device has been exchanged with a backup device.No patient has occurred.(b)(4).
 
Event Description
Complaint id: (b)(4).
 
Manufacturer Narrative
The reported failure "head error" occurred during patient treatment.The device has been exchanged.No patient harm occurred.The affected drive with s/n (b)(6) was sent back to manufacturer for repair.On 2021-05-10 emtec was able to reproduce the reported failure and the root cause was determined as misuse of the device, which lead to a damage circuit board mc1 and mc2.These were replaced by the supplier.A device history review (dhr) was performed on 2021-02-19 and the dhr does not show any abnormality or issue that is related or can have led to the customer.Based on these investigation results the reported failure could be confirmed.In order to avoid reoccurrence of the reported failure, the user will be informed to follow the chapter in the instruction for use heart-lung support system rotaflow system| 4.2 | en | v13.Chapter 4.1.3: switch off the rotaflow console on/off switch before connecting the rotaflow drive to or disconnecting it from the rotaflow console.Otherwise the rotaflow console may be damaged.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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key11284816
MDR Text Key230443286
Report Number8010762-2021-00100
Device Sequence Number1
Product Code KFM
Combination Product (y/n)N
PMA/PMN Number
K991864
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial,Followup
Report Date 05/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberROTAFLOW
Device Catalogue Number70102.2161
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/08/2021
Initial Date Manufacturer Received 01/29/2021
Initial Date FDA Received02/05/2021
Supplement Dates Manufacturer Received05/18/2021
Supplement Dates FDA Received05/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-