MAUDE Adverse Event Report: NIPRO CORPORATION USD EXELTRA; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number	5M2119
Medical Device Problem Codes	Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that there was a poor connection between the dialyzer and the bloodlines.The connections did not feel secure to the customer and there was some blood leaking around the connections.The reporter stated that it took effort to ensure that the lines were seated just right.This issue was noted about one hour into the therapy.The therapy was discontinued and a new set was used.There was no patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
A batch review was conducted and there were no deviations found related to this reported condition during the manufacturing of this lot.The actual device was not received for evaluation; therefore, a device analysis could not be completed.However, a retention sample was evaluated for the reported event.The retention sample was visually inspected and no abnormalities were found on an arterial or venous header.The dimensions of the headers were measured and they were found to be within specifications.The reported event was not verified.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: EXELTRA
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): NIPRO CORPORATION USD; ohdate-shi
• MDR Report Key: 7548938
• Report Number: 1416980-2018-03214
• Device Sequence Number: 19256904
• Product Code: KDI
• UDI-Device Identifier: 00085412071275
• UDI-Public: (01)00085412071275
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K030974
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2018

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: 12/31/2019
• Device Catalogue Number: 5M2119
• Device Lot Number: 17A16E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/02/2018
• Supplement Date Received by Manufacturer: 07/09/2018
• Initial Report FDA Received Date: 05/29/2018
• Supplement Report FDA Received Date: 08/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1