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

Model Number OP-05W(A)

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 06/28/2018

Event Type  Injury  

Manufacturer Narrative

The product in complaint was not returned to the manufacturer and could not be analyzed.The lot number in complaint was not reported and we could not review the manufacturing and quality control records.According to physician's comment, the patient was treated with the anticoagulant for her first time, so the relationship between anticoagulant and the event of "blood pressure decreased" cannot be ruled out, but as after definite period of time from the start of the treatment the patient developed "blood pressure decreased", so the causal relationship of adsorption column to the event is very likely.We decided to submit this case because the causal relationship between this event and the plasmaflo op could not be denied however the physician considers the causal relationship between this event and immusorba tr350 cannot be ruled out."blood pressure decreased" is written in the package insert as the event ("hypotonia") to monitor during the treatment.This ae might have occurred in part or in total related to the patient's physiology.Plasmaflo op is used as plasma separator and immusorba tr-350 is used for immunoadsorption column for separated plasma.This incident occurred in (b)(6) and is reported to fda according to the requirement.

Event Description

The female patient experienced the following adverse event in (b)(6).The female patient, whose blood pressure was 110mmhg, was started the treatment of the immunoadsorption plasmapheresis (iapp) with the plasma separator (plasmaflo op-05w), which was a similar product of plasmaflo op-05w(a) sold in u.S.After 75 minutes the treatment started, her blood pressure (bp) decreased to 40 mmhg rapidly.She was given the treatment of elevation of lower extremities and with the normal saline solution 500ml intravenously, and was given oxygen 4l.After 30 minutes, she was started with the treatment of the normal saline solution intravenously by her blood access.After 15 minutes her blood pressure recovered to 100mmhg, she went back to her hospital ward.This was her first time for her treatment of iapp, but after this event she was not given such treatment.

• 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, oita 870-0 396; JA 870-0396
• Manufacturer Contact: akitake yamashita ; 1-1-2 yurakucho, chiyoda-ku; tokyo 100-0-006 ; JA 100-0006
• MDR Report Key: 7804167
• MDR Text Key: 117836228
• Report Number: 8010002-2018-00170
• 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: 07/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: OP-05W(A)
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2018
• 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
• Treatment: AMOXICILLIN 250 MG; ANGIOTENSIN II RECEPTOR BLOCKER; FUTHAN (NAFAMOSTAT MESILATE) 30 MG/U; IMMUSORBA TR-350; MESTINON (PYRIDOSTIGMINE BROMIDE) 60 MG; PREDONINE (PREDNISOLONE) 5 MG; PROGRAF (TACROLIMUS HYDRATE) 1 MG
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Weight: 49