ASAHI REXEED-S SERIES DIALYZERS REXEED-21S N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-24 for ASAHI REXEED-S SERIES DIALYZERS REXEED-21S N/A manufactured by Asahi Kasei Medical Co., Ltd..

Event Text Entries

[187693706] The actual product was not returned to our company, but lot number was known, so we investigated manufacturing and quality control records of lot# aj5e5n. As a result, no abnormality was found in records. No similar event using this lot# aj5e5n was reported globally. This incident of "shortness of breath" occurred, and we could not receive doctor's judgement, but we decided to report this incident since we consider "shortness of breath" was the serious adverse event. The causal relationship between this case and this product is unknown. The shortness of breath 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. " moreover, we consider blood leak from the arterial header is an incident which might cause serious injury to the patient. The blood leakage is described in warnings of the instructions for use as "in the event of a problem during treatment, such as blood leakage or coagulation, immediately discontinue the treatment under the direction of a physician and replace rexeed-s with a new primed dialyzer". Additionally, about the health status and the reasons for the patient who was transported to the er, a number of phone and email contacts were made with our u. S. A. Staff and agents. However, no answer was obtained. We will continue monitoring occurrence of these kinds of incidents.
Patient Sequence No: 1, Text Type: N, H10


[187693707] The dialyzer on the machine cracked and started leaking blood. Approx. 200-300 ml blood was wasted which included spillage on floor, lines and dialyzer. The patient started complaining of nausea, and dry heaving. Emesis of 30 ml brownish sputum was observed. 300 ml normal saline was given to the patient for comfort. The patient started to then complain of shortness of breath. Use of accessory muscles was noted. Rapid response initiated. Non-rebreather mask bs-193 was placed on the patient. The patient transported to er via stretcher with nod and respiratory.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3007340888-2020-00020
MDR Report Key9870968
Report SourceUSER FACILITY
Date Received2020-03-24
Date of Report2020-03-02
Date of Event2019-11-02
Date Mfgr Received2020-03-02
Device Manufacturer Date2019-05-23
Date Added to Maude2020-03-24
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. AKITAKE YAMASHITA
Manufacturer Street1-1-2 YURAKUCHO CHIYODA-KU
Manufacturer CityTOKYO, 100-0006
Manufacturer CountryJA
Manufacturer Postal100-0006
Manufacturer G1ASAHI KASEI MEDICAL MT CORP. OKATOMI PLANT
Manufacturer Street5-4960 NAKAGAWARA-MACHI
Manufacturer CityNOBEOKA-SHI, 882-0031
Manufacturer CountryJA
Manufacturer Postal Code882-0031
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameASAHI REXEED-S SERIES DIALYZERS
Generic NameDIALYZER, HIGH PERMEABILITY, PRODUCT CODE: KDI
Product CodeKDI
Date Received2020-03-24
Model NumberREXEED-21S
Catalog NumberN/A
Lot NumberAJ5E5N
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerASAHI KASEI MEDICAL CO., LTD.
Manufacturer Address1-1-2 YURAKUCHO CHIYODA-KU TOKYO, 100-0006 JA 100-0006


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-24

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