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

Model Number OP-08D

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

Patient Problem Urticaria (2278)

Event Date 03/20/2023

Event Type  Injury  

Manufacturer Narrative

The product of this event was not returned to the manufacturer and could not be analyzed.There is no information on physician's opinion regarding seriousness and causal relationship between this event and the use of the medical device.We consider urticaria as "serious injury" since it was a systemic urticaria and steroids are being administered via iv as a treatment, and the causal relationship between the urticaria and the use of the medical device cannot be denied.Urticaria is described as one of the adverse events in "e.Precautions" of ifu.We will continue to monitor the occurrence of similar events carefully.

Event Description

This incident occurred in japan.Plasmaflo op-d series is identical model to op-05w(a) marketed in us.Patient with chronic inflammatory demyelinating polyradiculoneuropathy received simple plasma exchange treatments using op-08d.Albumin was used as replacement fluid.Five minutes after the 5th treatment on (b)(6) 2023, urticaria developed throughout the body and treatment was discontinued.Drug allergy was suspected, and loxoprofen sodium hydrate and nafamostat mesilate were discontinued.After discontinuing treatment, steroid was administered via iv, but it was discontinued due to severe drowsiness.About 15 minutes after the start of the 6th treatment on (b)(6) 2023, urticaria also appeared all over the body, but the treatment was continued.At the time of this treatment, no drug was used.Patient's symptom was improved after completion of 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.; 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: 16721660
• MDR Text Key: 313140347
• Report Number: 8010002-2023-00020
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: OP-08D
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2023
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Other