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

Catalog Number 5M2119

Device Problems Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event 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.

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
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): NIPRO CORPORATION USD; ohdate-shi
• Manufacturer (Section G): NIPRO CORPORATION USD; 8-7 hanuki-yachi, niida-aza; ohdate-shi 01857 94; JA 0185794
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 7548938
• MDR Text Key: 109803799
• Report Number: 1416980-2018-03214
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00085412071275
• UDI-Public: (01)00085412071275
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030974
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 5M2119
• Device Lot Number: 17A16E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/09/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1