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..
[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
| Report Number | 3007340888-2020-00020 |
| MDR Report Key | 9870968 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-02 |
| Date of Event | 2019-11-02 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2019-05-23 |
| Date Added to Maude | 2020-03-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. AKITAKE YAMASHITA |
| Manufacturer Street | 1-1-2 YURAKUCHO CHIYODA-KU |
| Manufacturer City | TOKYO, 100-0006 |
| Manufacturer Country | JA |
| Manufacturer Postal | 100-0006 |
| Manufacturer G1 | ASAHI KASEI MEDICAL MT CORP. OKATOMI PLANT |
| Manufacturer Street | 5-4960 NAKAGAWARA-MACHI |
| Manufacturer City | NOBEOKA-SHI, 882-0031 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 882-0031 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASAHI REXEED-S SERIES DIALYZERS |
| Generic Name | DIALYZER, HIGH PERMEABILITY, PRODUCT CODE: KDI |
| Product Code | KDI |
| Date Received | 2020-03-24 |
| Model Number | REXEED-21S |
| Catalog Number | N/A |
| Lot Number | AJ5E5N |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASAHI KASEI MEDICAL CO., LTD. |
| Manufacturer Address | 1-1-2 YURAKUCHO CHIYODA-KU TOKYO, 100-0006 JA 100-0006 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-24 |