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

Model Number OP-05W(L)

Device Problem Biocompatibility (2886)

Patient Problem Anaphylactic Shock (1703)

Event Date 06/05/2020

Event Type  Injury  

Manufacturer Narrative

The medical device was not returned and could not be analyzed.No abnormalities were found in the manufacturing and shipping records of the lot.The doctor commented that the causal relationship of use of the medical device is possible and the severity is life-threatening since this case might have lead to serious illness or death if the patient had been left untreated.We determined to report this incident since the causal relationship between the anaphylactic reaction and the use of the medical device cannot be denied, and the anaphylactic reaction is serious and the patient was hospitalized after the treatment.Anaphylactic reaction is currently not mentioned in warnings of the instruction for use, but this is the first case for the past 5 years reported for this medical device.Hence, we will continue to monitor similar complaints carefully.

Event Description

This case occurred in (b)(6).This patient had immunoadsorption therapy using the medical device of plasmaflo op-05w(l), which is used as plasma separator and is a similar product to plasmaflo op-05w(a) marketed in us, and immusorba tr-350(l) which adsorbs substances in separated plasma and is not marketed in us.On (b)(6) 2020 at 12:14, immediately after connecting patient's catheter to immunoadsorption device (plasmaflo op-05w(l) and immusorba tr-350(l)), anaphylactic reaction including hypotension, vertigo, nausea without vomiting, severe sweating was observed.1 ampoule of fenistil i.V.And 100 mg prednisone i.V.Were administered and immunoadsorption paused briefly.Then the patient's condition improved rapidly.Thereafter, immunoadsorption was performed as planned and ended at 13:45.The patient was admitted to neurological intermediate care unit for one night.On (b)(6), immunoadsorption was performed as planned with premedication of 1 ampoule of fenistil and 100 mg prednisone each and no event occurred during the 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, 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: 10342845
• MDR Text Key: 202088202
• Report Number: 8010002-2020-00090
• Device Sequence Number: 1
• Product Code: MDP
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 07/02/2020

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 Expiration Date: 09/30/2022
• Device Model Number: OP-05W(L)
• Device Catalogue Number: N/A
• Device Lot Number: VJ9QX3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/02/2020
• Initial Date FDA Received: 07/30/2020
• 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; Life Threatening