MAUDE Adverse Event Report: ASAHI KASEI MEDICAL CO., LTD ASAHI REXEED SX/LX DIALYZERS; DIALYZER, HIGH PERMEABILITY

Model Number REXEED-21AX

Device Problem Biocompatibility (2886)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 09/18/2014

Event Type  Injury  

Event Description

On (b)(6) 2014: same pt reported in #3007340888-2014-00010.During first session of rexeed-21ax treatment, atrial pressure dropped below 80.Administration: 60mg of prednisolone.Dialysis session was terminated.Immediate relief after disconnection.

Manufacturer Narrative

This incident occurred in (b)(6) and is reported to fda according to the requirement.Rexeed-21ax is identical model to rexeed-21sx marketed in us.The symptoms observed in the events are considered to be a dialyser reaction.Note: the dialyzer reaction is a broad group of events that include both anaphylactic and les swell defined adverse reactions of unk cause."handbook of dialysis 4th edition.".

• Brand Name: ASAHI REXEED SX/LX DIALYZERS
• Type of Device: DIALYZER, HIGH PERMEABILITY
• Manufacturer (Section D): ASAHI KASEI MEDICAL CO., LTD; tokyo ; JA
• Manufacturer (Section G): ASAHI KASEI MEDICAL MT CORP.
• Manufacturer Contact: tomoki maekawa ; 1-105 kanda jinbocho; chiyoda-ku, tokyo 101-8-101 ; JA 101-8101 ; 32963735
• MDR Report Key: 4223600
• MDR Text Key: 18093843
• Report Number: 3007340888-2014-00020
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: K121409
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2016
• Device Model Number: REXEED-21AX
• Device Lot Number: 1AXKXU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DIALYSIS MACHINE: GAMBRO INNOVA
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Weight: 88