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

Model Number APS-11SA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Shock (2072)

Event Date 03/06/2021

Event Type  Injury  

Manufacturer Narrative

The product of this event was not returned to the manufacturer and could not be analyzed; however, we investigated manufacturing and quality control records based on the lot number.According to the investigation, no potential for malfunction was found and no similar event has been reported with this lot number globally so far.The physician determined, this event as "serious injury" and these described adverse events as anaphylactoid reactions.We determined to report this incident since we also consider anaphylactoid reactions as "serious injury" and the causal relationship between the anaphylactic reaction and the use of the medical device cannot be denied "anaphylactoid reaction" or "shock" are not written in adverse reactions in ifu of rexeed-s, but it is described regarding hypersensitivity and hypotension 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 should be discontinued if signs or symptoms of hypersensitivity are exhibited." and "side effects such as hypertension, hypotension, headache, and nausea that may be associated with hypovolemia or hypervolemia can usually be avoided by careful management of the patient's fluid, electrolyte balance, blood flow rate, and transmembrane pressure (tmp)." we will continue to monitor the occurrence of similar events carefully.

Event Description

This incident occurred in (b)(6).Aps-sa series is identical model to rexeed-s series marketed in us.On (b)(6) 2021, at 9:28: the patient complained of feeling poorly and anaphylactoid reaction occurred 2 to 3 minutes after initiation of dialysis using other company's product.On (b)(6) 2021, at 9:39: 100 ml of fluid replacement was administered to increase blood pressure, but there was no improvement.On (b)(6) 2021, at 9:40: code blue was announced.Blood return was performed, and the patient was admitted to the icu.After the blood return, breathing and blood pressure were promptly recovered and code blue was released.On (b)(6) 2021: since hemodialysis was discontinued the day before, hemodialysis was performed using aps-11sa this time.The treatment was performed without any problems.On (b)(6) 2021, at 10:52: hemodialysis was initiated using aps-11sa.On (b)(6) 2021, at 10:55: the patient complained of numbness in upper and lower extremities and feeling poorly.Blood pressure decreased from 159 mmhg to 100 mmhg.Due to anaphylactoid reaction in patients, code blue was announced.On (b)(6) 2021, 10:57: blood return was started.On (b)(6) 2021, 11:09: hemodialysis was completed.The patient was intubated due to decreased spo2, and oxygenation was administered.After the ct scan was performed, the patient was admitted to the icu and at admission, consciousness level improved.There were no findings in ct scan, and blood pressure was recovered.On (b)(6) 2021, at 12:00: hemodialysis was performed with parnaparin sodium using other company's product for 3 hours without any problems.

• 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.; 2111-2; oaza sato; oita-shi, 870-0 396; JA 870-0396
• Manufacturer Contact: naomi kagami ; 1-1-2 yurakucho; chiyoda-ku; tokyo, 100-0-006 ; JA 100-0006
• MDR Report Key: 11606748
• MDR Text Key: 260833932
• Report Number: 8010002-2021-00020
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K153344
• 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: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: APS-11SA
• Device Catalogue Number: N/A
• Device Lot Number: XK6H6R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2020
• 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
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Weight: 68