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

Model Number REXEED-25A

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 03/28/2018

Event Type  Injury  

Manufacturer Narrative

This incident of "hypersensitivity reaction" occurred in (b)(6) and is reported to fda according to the requirement. Rexeed-25a is identical model to rexeed-25s marketed in us. We could not receive the actual product so far. However, we investigated manufacturing and quality control records based on the lot number. We have not received any similar event under this lot number. We decided to report this incident since we consider hypersensitivity reaction which include dyspnea at rest to be the serious adverse event. The hypersensitivity reaction is described in 4. Adverse reactions of the instructions for use as "patients with a history of hypersensitivity reactions or those prone to hypersensitivity should be carefully monitored by the physician. It is recommended that, based on the physicians directions, treatment be discontinued if signs or symptoms of hypersensitivity are exhibited. These include acute shortness of breath with wheezing; respiratory arrest; itching; hives; generalized or localized redness of the skin; edema of the face, hands, or feet; hypertension above the baseline; elevated pulse rate; arrhythmia; ocular hyperemia; hypoesthesia; fever; leukopenia; and thrombocytopenia. ".

Event Description

On (b)(6) 2018 as soon as the male patient has started the treatment with rexeed-25a, which is a similar product of rexeed-25s, he was not feeling well, and experienced hypersensitivity reaction (hot tongue ; heavy salty taste in mouth, abdominal and thoracic oppression, dyspnea, laryngeal edema, generalized pruritus all over his body). Treatment to his hypersensitivity reaction: blood recovery, disconnection of the treatment, oxygen therapy, and solumedrol (corticosteroids) : 10 mg. His electrocardiogram and blood test was performed. After 30 min, his symptoms disappeared, and the patient was given the treatment with another dialysis machine.

• Brand Name: ASAHI REXEED-S SERIES DIALYZERS
• Type of Device: DIALYZER, HIGH PERMEABILITY
• Manufacturer (Section D): ASAHI KASEI MEDICAL CO., LTD.; 1-1-2 yurakucho; chiyoda-ku; tokyo 100-0 006; JA 100-0006
• Manufacturer (Section G): ASAHI KASEI MEDICAL MT CORP.; oita works; 2111-2 oaza sato; oita-shi, oita 870-0 396; JA 870-0396
• Manufacturer Contact: akitake yamashita ; 1-1-2 yurakucho, chiyoda-ku; tokyo 100-0-006 ; JA 100-0006
• MDR Report Key: 8072831
• MDR Text Key: 127203511
• Report Number: 8010002-2018-00210
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K153344
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 10/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 07/31/2020
• Device Model Number: REXEED-25A
• Device Catalogue Number: N/A
• Device Lot Number: QG797B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 11/15/2018 Patient Sequence Number: 1