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

Catalog Number	800541
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event date was reported as a few weeks before (b)(6) 2018.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that an external fluid leak occurred on a mars kit, after set-up and during priming.The location of the leak was not identified.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
The device was received for evaluation.A visual inspection and a pressure test were performed and with no abnormalities that could have contributed to the reported condition identified.The reported condition was not verified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: MARS
• Common Device Name: APPARATUS, HEMOPERFUSION, SORBENT
• Manufacturer (Section D): BAXTER HEALTHCARE - ROSTOCK; rostock
• MDR Report Key: 7948494
• Report Number: 3007697864-2018-00007
• Device Sequence Number: 13827827
• Product Code: FLD
• UDI-Device Identifier: 37332414107728
• UDI-Public: (01)37332414107728
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K133807
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2018
• Report Date (Section F): 10/09/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 800541
• Device Lot Number: 0000023457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2018
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/14/2018
• Event Location: Other
• Date Report to Manufacturer: 10/09/2018
• Initial Date Received by Manufacturer: 09/14/2018
• Supplement Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 10/09/2018
• Supplement Report FDA Received Date: 11/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 10/09/2018