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

Model Number PLASMAFLO OP

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Chest Pain (1776); Dyspnea (1816); Rash (2033)

Event Date 01/12/2018

Event Type  Injury  

Manufacturer Narrative

This incident of dyspnea occurred in (b)(6).And we are reporting this event to fda according to the requirement.Plasmaflo op-08w(l) is similar model of plasmaflo op-05w(a) marketed in u.S.The actual used products were not returned to u.S for investigation and could not be analyzed, however the lot number was reported.So we reviewed manufacturing records and quality records of lot#fg4p4u.As a result, no abnormality was found in the records.(b)(4) units of this lot#fg4p4u were manufactured and no similar event using this lot#fg4p4u was reported globally.Difficulty breathing(dyspnea), urticaria(cutaneous rash), and chest pain such as this case may occur during dialysis treatment and/or extracorporeal treatment from multiple factors such as patient condition (including primary disease and treatment condition), dialyzer (membrane material and compatibility), blood tubing, operating condition, treatment condition, medication interactions including anticoagulants and others.The caution for this event is described in instruction for use.Patient's physician considers that this case is serious event and that causal relationship between plasmaflo op and this event is possible, and reported this case to french competent authority.We also consider the severity of dyspnea is serious injury as patient's oxygen saturation decreased to 80% , and the causal relationship between this device and the event could not be denied because the event happened during the treatment.

Event Description

A (b)(6)-year-old man was alternatively given the treatment with plasmapheresis(five pe sessions), and double filtration plasma apheresis(dfpp) of plasmaflo op-o8w(l) and cascadeflo ec-30w, and sodium citrate hydrate (acd-a) as the anticoagulant on plasauto sigma(two sessions).Patient experienced adverse events during 1st and 2nd dfpp as follows.(b)(6) 2018: after 5 min.From the beginning of fresh frozen plasma(ffp) infusion of dfpp, this patient developed choking sensations, drop of oxygen saturation to 80%, and cutaneous rash.The treatment was stopped.The patient was given the treatment of oxygen and iv polaramine (anti-histamine).(b)(6) 2018: after 10 min.From the patient's connection to dfpp(infusion of 4% albumin), he developed choking sensations, chest pains on the left side, and drop of oxygen saturation to 88%.Treatment of dfpp continued with iv polaramine (anti-histamine).He has recovered from the symptoms.On the other hand, this patient suffered similar adverse effects during a pe session on prismaflex with ffp on (b)(6) 2018 and with albumin on (b)(6) 2018.

• Brand Name: PLASMAFLO OP
• Type of Device: PLASMA SEPARATOR
• Manufacturer (Section D): ASAHI KASEI MEDICAL CO., LTD.; 1-105, kanda jinbocho,; chiyoda-ku,; tokyo 101-8 101; JA 101-8101
• Manufacturer (Section G): ASAHI KASEI MEDICAL MT CORP.; oita works; 2111-2 oaza sato,; oita-shi, oita 870-0 396; JA 870-0396
• Manufacturer Contact: akitake yamashita ; 1-105, kanda jinbocho,; chiyoda-ku,; tokyo 101-8-101 ; JA 101-8101 ; 32963735
• MDR Report Key: 7446041
• MDR Text Key: 106012200
• Report Number: 8010002-2018-00020
• Device Sequence Number: 1
• Product Code: MDP
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 03/23/2018

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 Expiration Date: 03/31/2020
• Device Model Number: PLASMAFLO OP
• Device Catalogue Number: OP-08W(L)
• Device Lot Number: FG4P4U
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/23/2018
• Initial Date FDA Received: 04/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2017
• 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
• Treatment: 4% ALBUMIN; CASCADEFLO EC-30W; FRESH FROZEN PLASMA(FFP); PLASAUTO SIGMA
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Weight: 80