MAUDE Adverse Event Report: BAXTER HEALTHCARE - MEYZIEU PRISMAFLEX HF1400; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number	107142
Medical Device Problem Codes	Fluid/Blood Leak (1250); Hole In Material (1293)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection revealed no defect that could have caused the reported event.The cause of the condition could not be determined.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that an external leak occurred on a prisma flex hf1400 tubing.The leak was observed to be coming from a pin hole in the set that resulted in saline squirting out during priming.There was no patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
The initial mdr is being corrected to 24 may 2018.The external leak observed on a prismaflex hf1400 tubing occurred within a few minutes into treatment.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAFLEX HF1400
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - MEYZIEU; meyzieu
• MDR Report Key: 7601993
• Report Number: 8010182-2018-00052
• Device Sequence Number: 16195512
• Product Code: KDI
• UDI-Device Identifier: 07332414069315
• UDI-Public: (01)07332414069315
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K042938
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2018
• Report Date (Section F): 06/14/2018

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: 12/01/2019
• Device Catalogue Number: 107142
• Device Lot Number: 17L0503
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/17/2018
• Event Location: Hospital
• Date Report to Manufacturer: 06/14/2018
• Initial Date Received by Manufacturer: 05/17/2018
• Supplement Date Received by Manufacturer: 06/15/2018
• Initial Report FDA Received Date: 06/14/2018
• Supplement Report FDA Received Date: 06/21/2018
• 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: 06/14/2018