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

Model Number APS-15SA

Device Problem Biocompatibility (2886)

Patient Problem Thrombocytopenia (4431)

Event Date 05/11/2021

Event Type  Injury  

Manufacturer Narrative

Analysis of this product: this product was discarded at the hospital when the report was received from the hospital, and this product could not be analyzed.Survey results of manufacturing records: when the manufacturing record and the inspection record at the time of shipment were confirmed based on the lot number, no abnormality was confirmed.Our view: eleven days before ((b)(6)) the dialysis treatment, using the same brand as this product, platelet count decreased from 60,000 / ul to 9,000 / ul after treatment, so the patient was hospitalized for the purpose of improving the platelet count.This time ((b)(6)) the platelet count after dialysis treatment using this product was 16,000 /ul, and the patient was hospitalized because there was no improvement, so it was judged as serious.The physician also considers it is serious.(the event on (b)(6) will be reported in a separate report.) the platelet count before this dialysis treatment (may 11) unknown, but eleven days before ((b)(6)), a platelet count decrease from 60,000 / ul to 9,000 / ul was confirmed before and after dialysis treatment with the same brand as this product.It cannot be denied that the platelet count may have decreased after this treatment.Physician also suspect a causal relationship with this product.But on the other hand (1) the patient continued to use this brand three times a week for one month before the onset of this event, and no problem occurred during that time.(2) it has been confirmed that it took time to stop bleeding after dialysis even before the occurrence of this event (previously, it took about 10 to 15 minutes instead of about 5 minutes).(3) thrombocytopenia was not seen after switching to another company's dialyzer in the treatment on may 13, but the anticoagulant was also changed in that treatment.From the above three points, it cannot be concluded that thrombocytopenia was caused by this product, and the cause cannot be identified.We decided to report this incident since we consider thrombocytopenia as serious adverse event.The thrombocytopenia is described in 4.Adverse reactions of the instructions for use as "side effects such 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.We will continue to monitor the occurrence of similar event carefully.

Event Description

Hemodialysis therapy was performed for the patient with end-stage renal disease.This incident occurred in (b)(6) and is reported to fda according to the requirement.Aps-15sa is identical model to rexeed-s series marketed in us.From (b)(6) 2021, dialysis treatment using the same brand as this product was started three times a week.(b)(6).Platelet count before dialysis 60,000 / ul, platelet count after dialysis 60,000 / ul.(b)(6).Platelet count 60,000 / ul after dialysis.From around this time, the bleeding time at the end of dialysis tends to be extended (from 5 minutes to 10 to 15 minutes).(b)(6).200 cc of blood leaked from the shunt part 20 minutes after the start of dialysis using this product.300 ml of fluid replacement was performed because of the blood pressure decreased to 100/70 mmhg.Vomiting developed 1 hour after the start of dialysis, and blood pressure was decreased to 110/70 mmhg.The patient recovered after treatment and completed dialysis.(b)(6).It was found that the patient's platelet count on (b)(6) was 60,000 / ul before dialysis and 9,000 / ul after dialysis.The patient was hospitalized to improve platelet counts.The anticoagulant was changed from heparin to nafamostat mesilate.(b)(6).The platelet count of patient after dialysis with the same brand as this product is 16,000 / ul.(b)(6).The dialyzer was changed to another company's dialyzer that was used before (b)(6), and the anticoagulant was changed from nafamostat mesilate to low molecular weight heparin.The patient's platelet count was 40,000 / ul before dialysis and 40,000 / ul after dialysis.(b)(6).Confirmed the patient's platelet count of 60,000 / ul.The patient was discharged.(b)(6).Patients were treated with another company's dialyzer and anticoagulant low-molecular-weight heparin.The patient's platelet count was 60,000 / ul before dialysis and 60,000 / ul after dialysis.This report is on the event that occurred on (b)(6) 2021.

• Brand Name: ASAHI REXEED-S SERIRS 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, 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: 12132555
• MDR Text Key: 271479036
• Report Number: 8010002-2021-00060
• 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,user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2021
• 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-15SA
• Device Catalogue Number: N/A
• Device Lot Number: VK7P7S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2020
• 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
• Patient Age: 84 YR
• Patient Weight: 43