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

Catalog Number H25601A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Rash (2033); Reaction (2414)

Event Date 03/02/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

A hemodialysis patient experienced a rash which occurred following treatment after using a xenium dialyzer.The patient was treated with loratadine (dose, route, frequency and duration not reported).The filter was changed, therapy end regularly and the patient was discharged.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 manufacture of this lot.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.

• Brand Name: XENIUM XPH
• 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 hanukiyachi, niida-aza; odate-shi ; JA
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 6435440
• MDR Text Key: 70878796
• Report Number: 1416980-2017-02658
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K083778
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 05/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: H25601A
• Device Lot Number: 15H27A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR