MARS 800473

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-02-12 for MARS 800473 manufactured by Baxter Healthcare - Rostock.

Event Text Entries

[100052092] Recall - 3007697864-12/12/2017-001-r. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. The device was received for evaluation. Visual inspection revealed that the line was detached from the hansen connector at unit 1. The reported condition was verified. The cause of the condition was determined to be an insufficient gluing of the corresponding line to unit 1 during the manufacture of the set. A nonconformance has been opened to address this issue. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[100052093] It was reported that the albumin line connection joint of a mars kit did not hold and got separated at the beginning of treatment. Two nurses were exposed to the leak. The start of the treatment was delayed approximately 2 hours; however, according to the nurse this delay did not affect the condition of the patient. There was no patient or nurse injury or medical intervention associated with this event. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3007697864-2018-00003
MDR Report Key7264275
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2018-02-12
Date of Report2018-02-12
Date of Event2018-01-16
Date Mfgr Received2018-01-19
Date Added to Maude2018-02-12
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer Street25212 W. ILLINOIS ROUTE 120
Manufacturer CityROUND LAKE IL 60073
Manufacturer CountryUS
Manufacturer Postal60073
Manufacturer Phone2242702068
Manufacturer G1BAXTER HEALTHCARE - ROSTOCK
Manufacturer StreetFRIEDRICH-BARNEWITZ-STRASSE 4
Manufacturer CityROSTOCK 18119
Manufacturer CountryGM
Manufacturer Postal Code18119
Single Use3
Remedial ActionRC
Previous Use Code3
Removal Correction NumberSEE H10
Event Type3
Type of Report3

Device Details

Brand NameMARS
Generic NameAPPARATUS, HEMOPERFUSION, SORBENT
Product CodeFLD
Date Received2018-02-12
Returned To Mfg2018-01-31
Model NumberNA
Catalog Number800473
Lot Number0000022819
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBAXTER HEALTHCARE - ROSTOCK
Manufacturer AddressROSTOCK


Patients

Patient NumberTreatmentOutcomeDate
10 2018-02-12

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