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

Model Number REXEED-21LX

Device Problem Biocompatibility (2886)

Patient Problems Low Blood Pressure/ Hypotension (1914); Respiratory Distress (2045); Chest Tightness/Pressure (2463)

Event Date 09/29/2014

Event Type  Injury  

Event Description

On (b)(6) 2014: pt had some complications like arterial pressure drop, breathlessness but they completed the treatment.On (b)(6) 2014: 5min after start of treatment, arterial pressure dropped from 130/80mmhg to 80/45mmhg, respiratory affection, chest pain, chil (body temperature 37.6 c), signs of myocardial ischemia in ecg.Dialysis session has been terminated, prednisolone administered.Quick relief with 30mins; normalization of ecg on the next day.On (b)(6) 2014: after switch to polyflux-21h, dialysis was conducted without complications.

Manufacturer Narrative

This incident occurred in (b)(6) and is reported to fda according to the requirement.The symptoms observed in the events are considered to be a dialyzer 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." this is 2nd sae for same lot# of rexeed-21lx and 3rd sae for rexeed-sx/lx dialyzer model in same site.So, we sent our employee with medical licence to the site for hearing.Dr.(b)(6), chief of dialysis unit, considers this case mostly as individual reaction to dialyzer membrane, not to specific lot of products.They use enough volume of saline for priming and any other wrong conduct in the site was not found.We will keep on watching the ae of this model worldwide.(b)(4).

• 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: 4223597
• MDR Text Key: 5002190
• Report Number: 3007340888-2014-00030
• 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: 08/31/2016
• Device Model Number: REXEED-21LX
• Device Lot Number: 9A8Y8M
• 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: 08/01/2013
• 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: 63 YR
• Patient Weight: 92