MAUDE Adverse Event Report: TP - GAMBRO DIALYSATOREN GMBH - SP004138 POLYFLUX 140H; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number	103530
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a polyflux 140 h set leaked at the housing during patient treatment.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
The device was not returned but 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: POLYFLUX 140H
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): TP - GAMBRO DIALYSATOREN GMBH - SP004138; hechingen
• MDR Report Key: 7611441
• Report Number: 1416980-2018-03702
• Device Sequence Number: 11049257
• Product Code: KDI
• UDI-Device Identifier: 07332414037925
• UDI-Public: (01)07332414037925
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K043342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2018

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: 03/31/2020
• Device Catalogue Number: 103530
• Device Lot Number: 7-5704-H-01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/22/2018
• Supplement Date Received by Manufacturer: 07/20/2018
• Initial Report FDA Received Date: 06/18/2018
• Supplement Report FDA Received Date: 07/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1