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

Model Number OP-05W(A)

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

Patient Problem Anaphylactic Shock (1703)

Event Date 05/18/2021

Event Type  Injury  

Manufacturer Narrative

Anaphylactic shock was evaluated as a severe event because it was grade 3 in the side effect severity classification in (b)(6).Possible causes include allergies due to the membrane material of the device, enhanced immune function of the patient, concomitant medications, etc.However, since there is no identifiable information, the cause cannot be determined.This product was discarded when the report was received, so the actual product could not be analyzed.The lot number is also unknown and the inspection record at the time of manufacture and shipment cannot be confirmed.Anaphylactic shock is described as anaphylactoid reactions in ifu." e.Precautions 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.Presence of hemoglobin in separated plasma, due to hemolysis.The other potential reactions due to available substitute fluid such as fresh frozen plasma, plasma protein fraction are anaphylactoid reactions, hypocalcemia and infection." we will continue to monitor the occurrence of similar events carefully.

Event Description

This case occurred in (b)(6).Blood purification therapy was performed for the patient with macroglobulinaemia.On (b)(6) 2021, the double filtration plasma filtration plasmapheresis (dfpp) therapy using the 1st filter, op-05d which is an identical product to op-05w(a) marketed in us was performed.30 minutes after the start of treatment the second filter was clogged and then the dfpp therapy was stopped.On (b)(6) 2021, only plasma exchange therapy was performed using op-05d, but about 30 minutes after the start of treatment, the patient suffered from anaphylactic shock and the treatment was discontinued.The patient improved by the medical treatment.After that, it was determined that chemotherapy would be the main treatment, and blood purification therapy would be postponed.

• 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: naomi kagami ; 1-1-2 yurakucho; chiyoda-ku; tokyo, 100-0-006 ; JA 100-0006
• MDR Report Key: 11981860
• MDR Text Key: 255601202
• Report Number: 8010002-2021-00040
• 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: 05/20/2021

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-05W(A)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/20/2021
• Initial Date FDA Received: 06/11/2021
• 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): Other
• Patient Weight: 65