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

Model Number APS-18SA

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

Patient Problem Shock (2072)

Event Date 03/31/2021

Event Type  Injury  

Manufacturer Narrative

Due to the two reasons described below, it is unlikely that the material of this product is the cause of the shock, and the cause of this event cannot be identified.Prior to the use of aps-18sa, the patient vital signs were stable when chf treatment was performed for about 7 hours using aef-10 made of the same material as aps-18sa.When chdf treatment was performed again using aef-10 made of the same material as aps-18sa after the patient's shock with aps-18sa, the patient vitality was stable even if catecholamine was reduced.On the other hand, hd treatment using aps-18sa and chf or chdf treatment using aef-10 differ in two points.One point is blood flow rate and the other point is membrane area.It is probable that the blood flow rate was higher during hd treatment with aps-18sa, and the membrane area of aps-18sa was larger, so the amount of blood drawn out of the body was larger, and the load on the patient was greater.(in this case, blood flow information at the time of treatment was not obtained, but the blood flow rate in hd treatment is recommended to be 100 to 300 ml/min in the ifu, and in most cases, it is performed at 200 ml/min.On the other hand, for chf and chdf, recommended blood flow rate is stated as 60 -100 ml/min in the ifu.In addition, the membrane area of aps-18sa is 1.8 m2 but the membrane area of the aef-10 was 1.0 m2.) we determined to report this incident since we also consider shock as "serious injury" and the causal relationship between the shock and the use of the medical device cannot be denied."shock" is 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 physician 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 case occurred in (b)(6).Blood purification therapy was performed for the patient with aspirin addiction.(b)(6) 2021,at 5:00 continuous hemofiltration (chf) was performed for 7 hours using excelflo aef-10 which is a filter for chf and marketed in (b)(6) to remove the drug.During this time, there was no abnormality in vital signs.Afterwards, hemodialysis (hd) was started at 12:00 to continue removal of the drug using aps-18sa which is an identical product to rexeed-18s marketed in us and 20 minutes later, the systolic blood pressure (sbp) dropped to 50 mmhg or less and the patient became shocked.Hd was temporarily stopped and catecholamine and 5% albumin were administered to increase the intravascular volume to cope with the shock condition.As a result, the sbp gradually increased and the sbp recovered to 100 mmhg level after 20 minutes.Hd was restarted using the same lot product of aps-18sa and was completed after about 7 hours, while continuous administration of catecholamine.To remove the drug, continuous hemodiafiltration (chdf) was performed again using aef-10, while administering catecholamine.After switching to chdf, the recovery tendency of sbp was observed, and catecholamine could be gradually reduced.

• 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.; 5-4960; nakagawara-machi; nobeoka-shi, 882-0 031; JA 882-0031
• Manufacturer Contact: naomi kagami ; 1-1-2 yurakucho; chiyoda-ku; tokyo, 100-0-006 ; JA 100-0006
• MDR Report Key: 11723073
• MDR Text Key: 247220315
• Report Number: 3007340888-2021-00010
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: APS-18SA
• Device Lot Number: AK6R75
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 47 YR
• Patient Weight: 67