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

Model Number APS-15SA

Device Problem Biocompatibility (2886)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 01/21/2020

Event Type  Injury  

Manufacturer Narrative

This incident of "hypotension" occurred in (b)(6) and is reported to fda according to the requirement.Aps-15sa is identical model to rexeed-15s marketed in us.We could not receive the actual product.However, we could obtain its lot number, so we investigated manufacturing and quality control records based on the lot number.We have not received any similar event under this lot number.We decided to report this incident since we consider hypotension to be the serious adverse event.The hypotension is described in 4.Adverse reactions of the instructions for use as "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).".

Event Description

This patient who had been given the treatment with the other company's dialyzer, was transferred from the other hospital to this hospital in order to be operated for the cancer of the large intestine.This patient was given the first treatment with dialyzer aps-15sa which is a similar product with rexeed-15s.In the following day, the patient was scheduled to be performed the operation, coahibitor(nafamostat mesilate) was used as anticoagulant.13 minutes before the start of treatment: blood pressure 123 mmhg.At the start of treatment: blood pressure 134 mmhg.2 minutes after the start of treatment: blood pressure dropped to 95 mmhg.6 minutes after the start of treatment: blood pressure 90 mmhg.9 minutes after the start of treatment: blood pressure 133 mmhg.10 minutes after the start of treatment: blood pressure 49 mmhg.The patient complained of tiredness, sweating and vomiting were noted.Elevation of the lower extremities, and the treatment was discontinued.The patient was conscious and was administered 500 ml of normal saline.12 minutes after the start of treatment: blood pressure 49 mmhg.As an additional treatment, adrenaline 0.1% / ml was injected subcutaneously into the left thigh.14 minutes after the start of treatment: blood pressure 54 mmhg.19 minutes after the start of treatment: blood pressure 70 mmhg.The treatment with inovan injection started at 3 ml / h.23 minutes after the start of treatment: administration of oxygen was started at 3 l / min due to 90% oxygen saturation.30 minutes after the start of treatment: because the blood pressure did not rise from 70 mmhg, administration of sol-medrol 125 mg, and normal saline 50 ml was started.Inovan injection increased to 5ml / h.The treatment with oxygen was increased to 5l / h because the patient's oxygen saturation was the 90s % level.34 minutes after the start of treatment: blood pressure 78 mmhg.36 minutes after the start of treatment: administration of 5 mg of poraramine, and normal saline 100 ml was started.38 minutes after the start of treatment: inovan injection was reduced to 3 ml / h and oxygen to 3 l / h because oxygen saturation was restored to 97%.40 minutes after the start of treatment: blood pressure 122 mmhg.50 minutes after the start of treatment: blood pressure 116 mmhg.Seven days after the onset of this event, the treatment with the other company's dialyzer and anticoagulant which were used by the previous physician, was started, but anticoagulant was changed to low-molecular-weight heparin.Although no abnormalities were observed halfway, the anticoagulant was changed to a coahibitor in the second half of the treatment, and after 10 minutes, itching appeared, and the patient was found to be allergic to nafamostat mesilate.

• 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.; okatomi plant; 5-4960; nakagawara-machi, nobeoka-shi 882-0 031; JA 882-0031
• Manufacturer Contact: akitake yamashita ; 1-1-2 yurakucho, chiyoda-ku; tokyo 100-0-006 ; JA 100-0006
• MDR Report Key: 9718051
• MDR Text Key: 192645706
• Report Number: 3007340888-2020-00010
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• 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,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: APS-15SA
• Device Catalogue Number: N/A
• Device Lot Number: AJ9LX1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening