MAUDE Adverse Event Report: ASAHI KASEI MEDICAL CO., LTD. PLASMAFLO OP; PLASMA SEPARATOR

Model Number OP-08W

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Loss of consciousness (2418)

Event Date 04/20/2020

Event Type  Injury  

Manufacturer Narrative

The product of this event was not returned to the manufacturer and could not be analyzed.The lot number of the product was not reported, and we could not review the manufacturing and quality control records.The physician's commented that the causal relationship between this event and plasmaflo op-08w and/or cascadeflo ec-20w was suspicious because adverse events occurred during treatment, but the possibility that albmin was the cause could not be denied.We considered that this event as "serious" because the patient experienced loss of consciousness.Also, we considered the causal relationship between the event and plasmaflo op-08w could not be denied because the patient experienced adverse events during the treatment and the physician commented as above.However, we cannot determine the cause of the events since this occurred for the first time in 2 years of patient's treatment, the physician did not deny the possibility that albumin is the cause, and the side effects of albumin includes shock and flushing.Hypotonia which is convertible term of hypotension is described in e.Precautions of ifu as "13 monitor the patient constantly during treatment with the plasmaflo¿ op-05w(a).In the event of any of the following during treatment, immediately ensure the safety of the patient and take appropriate measures in accordance with the directions of the responsible physician.- headache, nausea, vomiting, discomfort, chest pain, abdominal pain, hypotonia, hypertension, violent coughing, difficulty breathing, poor complexion, edema of eyelids, heart palpitation, dizziness, pyrexia, chill, causalgia, abnormal sweating, paresthesia, urticaria, muscle cramps, tinnitus, abnormal stimulation of the lachrymal glands, nasal blockage, or complaints of abnormal sensations of taste, smell, or itching, or any other adverse reaction or side effect observed in the patient." we will continue to monitor the occurrence of similar events carefully.

Event Description

This case occurred in (b)(6).This patient had double filtration plasma exchange therapy using the medical device of plasmaflo op-08w, which is used as plasma separator and is a similar product to plasmaflo op-05w(a) marketed in us, and cascadeflo ec-20w which separates substances in a certain molecular weight region from separated plasma and is marketed in (b)(6).Approximately 2 years ago, the patient experienced an allergic reaction to fresh frozen plasma during the simple plasma exchange therapy and since then, the patient has been treated with double filtration plasma exchange therapy.The double filtration plasma exchange therapy has been performed once per three months, but recently it has been perforemed once per month.April 20.11:00 double filtration plasma exchange therapy started.Hydrocortisone sodium succinate and d-chlorpheniramine maleate were administered to the patient at the beginning.Blood pressure was 122 mmhg.The treatment conditions are as follows.Blood pump flow rate : 80 to 100 ml / min.Plasma separation pump flow rate : 21%.Drain flow rate : 20% treatment volume : 3000 ml.Anticoagulant (heparin) : 2000u (1 shot) / 1400u (sustained).Albumin : 20% 250ml (50ml x 5 bottles).11:53 the patient appeared flushing symptoms.For the time being, the customer observed the situation.12:38 d-chlorpheniramine maleate was administered to the patient.Treatment continued because the symptom did not worsen.13:38 blood pressure decreased (88 mmhg) and the patient's consciousness was lost.The treatment was discontinued, and hydrocortisone sodium succinate and d-chlorpheniramine maleate were administered.Oxygen mask was introduced.14:00: patient's consciousness recovered, blood pressure increased (117 mmhg), and flushing symptoms recovered.

• Brand Name: PLASMAFLO OP
• Type of Device: PLASMA SEPARATOR
• 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: 10082016
• MDR Text Key: 195410302
• Report Number: 8010002-2020-00080
• Device Sequence Number: 1
• Product Code: MDP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P820033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: OP-08W
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/24/2020
• Initial Date FDA Received: 05/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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