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

Model Number PLASMAFLO OP

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

Patient Problem Complaint, Ill-Defined (2331)

Event Date 06/02/2015

Event Type  Injury  

Event Description

A hospitalized male patient experienced the following adverse event in (b)(6).(b)(6) 2015 the patient's blood pressure was 139/72 mmhg when he entered the treatment room.10:55 treatment of immunoadsorption plasmapheresis(iapp) with plasmaflo op started for the patient.The treatment condition was as follows; blood flow rate: 100ml/min., plasma flow rate:30ml/min.11:50 the patient's blood pressure decreased to 69/50 mmhg, so the treatment of iapp was stopped, and the blood was returned to the patient.Four minutes after the patient's blood returned, a half ampule of atropine injection was given.After two minutes, the patient did not recovered, so the patient was treated with rest half of atropine injection and then with veen-f inj.Intravenously.Nine minutes after the patient's blood returned, the patient's blood pressure recovered to 98/66 mmhg, while the patient's dysphoria remained.(b)(6) 2015 improvement of the patient's condition was confirmed.

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.Hypotension is listed in ifu as the event to monitor during the treatment.This ae might occurred in part or in total related to the patient's physiology.Plasmaflo op is used as plasma separator and immusorba tr is used for immunoadsorption colimn for separated plasma.This incident occurred in (b)(6) and is reported to fda according to the requirement.

• 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.; 2111-2 oaza sato,; oita, oita 870- 0396; JA 870-0396
• Manufacturer Contact: kaoru furuya ; 1-105, kanda jinbocho,; chiyoda-ku,; tokyo, 101-8-101 ; JA 101-8101
• MDR Report Key: 4880732
• MDR Text Key: 18295924
• Report Number: 8010002-2015-00010
• 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: 06/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PLASMAFLO OP
• Device Catalogue Number: OP-05W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2015
• 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: IMMUSORBA-TR350
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 90