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

Model Number REXEED-21A

Device Problem Biocompatibility (2886)

Patient Problems Low Blood Pressure/ Hypotension (1914); Hypoxia (1918); Nausea (1970)

Event Date 11/18/2013

Event Type  Injury  

Event Description

On (b)(6) 2013: 15-20min after start of treatment, the pt got fidget, sweating, hypoxia, nausea, and hypotension (140mmhg/90mmgh) then called physician administrated 1 ample of chlorpheniramine and dexamethasone i.V., gave oxygen and returned blood to the pt.Outcome of pt: recover.

Manufacturer Narrative

This incident occurred in (b)(4) 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 less well defined adverse reactions of unk cause."handbook of dialysis 4th edition.".

• Brand Name: REXEED SERIES 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; 2111-2 oaza sato; oita city, oita ; JA
• Manufacturer Contact: tomoki maekawa ; 1-105 kanda jinbocho; chiyoda-ku, tokyo 101-8-101 ; JA 101-8101 ; 32963735
• MDR Report Key: 4223602
• MDR Text Key: 4971529
• Report Number: 8010002-2014-00040
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K051187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/01/2014

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-21A
• Device Lot Number: QA858X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/01/2014
• 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: TUBING SET: BAIN; DIALYSIS MACHINE: FRESENIUS
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Weight: 65