MAUDE Adverse Event Report: ASAHI KASEI MEDICAL CO., LTD. ASAHI APS DIALYZERS

Model Number APS-21SA

Device Problem Biocompatibility (2886)

Patient Problem Shock (2072)

Event Date 02/16/2016

Event Type  Injury  

Manufacturer Narrative

This incident occurred in (b)(6) and is reported to fda according to the requirement.Aps-21sa is identical model to rexeed-21s marketed in us.The product in complaint was not returned to the manufacturer and could not be analyzed.We reviewed manufacturing records, quality records of lot# weynyr.As a result, no abnormality was found in records.(b)(4) units of this lot#weynyr were manufactured, and no similar event using this lot# weynyr was reported globally.The symptoms observed in the events might be 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 unknown cause."handbook of dialysis 4th ed." john t daugirdas et.Al., lippincott, williams & wilkins, 2006.Because of incompatibility of website and browser, we could not submit this mdr via web trader initially and sent paper mdr to fda by (b)(6).The paper mdr stamped with "(b)(6) 2016" (received date of fda), has been returned to us by post mail.

Event Description

(b)(6) 2016: the patient was given the online hdf treatment with dialyser (mfx-17meco).Just after the start of the treatment, he experienced shock symptom, then the dialysis was terminated, and he recovered.(b)(6) 2016: the treatment was changed back to that with the hemodialysis(hd) with the dialyser(aps-21sa).Soon after the start of the treatment, he has experienced anaphylactic reaction.He was given the treatment with some steroids(saxizon, predonin, celestamine) , and recovered.(b)(6) 2016: the patient was given the hd treatment with the other company's dialyser(fb210ub), and experienced an anaphylactic reaction soon after the start of the hd treatment. (b)(6) 2016: the treatment of the hemodialysis(hd) with the dialyser(aps-21sa, lot no 2exxxa) was started for the male patient hospitalized in japan.He was treated without any trouble.(b)(6) 2016: the treatment was changed to online hdf treatment with the other company's dialyser(mfx-17meco), and was completed without incident.(b)(6) 2016 the same treatment as on feb.4 was given to the patient without any trouble.(b)(6) 2016 the same treatment as above was given, and during the treatment he experienced a high fever of 40c.After the treatment, he has recovered to the normal temperature.(b)(6) 2016 the same treatment as above was given, and during the treatment he experienced a high fever of 40c again.He was hospitalized, was given the treatment, and recovered next day.His symptom was diagnosed as the suspicious bronchial infection.

• Brand Name: ASAHI APS DIALYZERS
• Type of Device: DIALYZER
• Manufacturer (Section D): ASAHI KASEI MEDICAL CO., LTD.; 1-105, kanda jimbocho,; chiyoda-ku,; tokyo, 101-8 101; JA 101-8101
• Manufacturer (Section G): ASAHI KASEI MEDICAL MT CORP. OITA WORKS; 2111-2 oaza sato,; oita-shi,; oita, oita 870-0 396; JA 870-0396
• Manufacturer Contact: kaoru furuya ; 1-105, kanda jinbocho,; chiyoda-ku,; tokyo, 101-8-101 ; JA 101-8101 ; 332963735
• MDR Report Key: 5610795
• MDR Text Key: 43714370
• Report Number: 8010002-2016-00010
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K051187
• 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: 02/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: APS-21SA
• Device Lot Number: WEYNYR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/23/2015
• 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: COAHIBITOR FOR INJECTION
• Patient Outcome(s): Life Threatening
• Patient Age: 68 YR
• Patient Weight: 48