Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - ROSTOCK MARS; APPARATUS, HEMOPERFUSION, SORBENT
  • 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
 

BAXTER HEALTHCARE - ROSTOCK MARS; APPARATUS, HEMOPERFUSION, SORBENT Back to Search Results
Catalog Number 800541
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/23/2018
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a leak was observed on a mars disposable at the 'truckler filter' during patient treatment.There was no patient injury or medical intervention associated with this event.No additional information is available.
 
Manufacturer Narrative
H10: the device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MARS
Type of Device
APPARATUS, HEMOPERFUSION, SORBENT
Manufacturer (Section D)
BAXTER HEALTHCARE - ROSTOCK
rostock
MDR Report Key8346624
MDR Text Key139604804
Report Number3007697864-2019-00001
Device Sequence Number1
Product Code FLD
Combination Product (y/n)N
PMA/PMN Number
K133807
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 02/17/2019,03/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number800541
Device Lot Number17F1905
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/17/2019
Distributor Facility Aware Date01/23/2019
Event Location Hospital
Date Report to Manufacturer02/17/2019
Date Manufacturer Received03/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-