MAUDE Adverse Event Report: BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER THERANOVA 400; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number	115578
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occurrence date was reported as last week of (b)(6) 2018.(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that two (2) units of theranova 400 had an external blood leakage from the header of the dialyzer during patient therapy.There was no patient injury or medical intervention associated with this event.No additional information available.
Additional Manufacturer Narrative
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.

• Brand Name: THERANOVA 400
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER; hechingen
• MDR Report Key: 7827863
• Report Number: 9611369-2018-00085
• Device Sequence Number: 19126561
• Product Code: KDI
• UDI-Device Identifier: 07332414114923
• UDI-Public: (01)07332414114923
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2018

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 Catalogue Number: 115578
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/07/2018
• Supplement Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 08/29/2018
• Supplement Report FDA Received Date: 09/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1