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

Model Number	OP-05W
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Shock (2072); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This incident occurred in (b)(6) and is reported to fda according to the requirement.Op-05w is identical model to op-05w(a) marketed in us.The product of this event was not returned to the manufacturer and could not be analyzed.The lot number of the product was not reported, and we could not review the manufacturing and quality control records.According to the physician's comment, the possibility of causal relationship of his treatments of immunoadsorption therapy to the aggravation of his beriberi, which was underlying disease before his admission, could not be denied.We considered that this event was serious adverse event because he experienced "shock".The causal relationship between the event and op was not denied, because we considered that the patient experienced "shock" after the treatment of op and causal relationship between op and the aggravation of beriberi could not be denied.The caution as to this event is not written in the package insert of op, we will continue to monitor the occurrence of these kinds of events.
Event or Problem Description
This case occurred in the facility of (b)(6).(b)(6) 2018 (the actual occurrence date is unknown.) the patient was admitted for his numbness and feelings of weakness at all of his extremities in an acute episode.The findings from test result showed acute motor sensory axonal neuropathy (hereinafter amsan), the subtype of the most severe of guillain-barre syndrome.Therefore, his symptom was considered as amsan and hyperventilation syndrome associated with respiratory myopathy, and he was started the immunoadsorption therapy using the medical device of plasmaflo op-o5w, which is used as plasma separator and is a similar product of plasmaflo op-05w(a) sold in us, and immusorba tr-350, which removes pathogenic substances by selective adsorption and is marketed in (b)(4).Hemodialysis was also performed at the same time because of renal disorder and hyperkalemia.The first treatment started at 14:00, the patient was given the treatment of immunoadsorption therapy of 1500 ml, and it finished in the evening.This patient experienced sudden circulatory failure at around 22 o'clock, mechanical ventilator was required, and continuous hemodiafiltration (chdf) was performed.Chest computed tomography(ct) showed no findings suggestive of pulmonary embolism thrombosis.The serum thiamine level measured at admission was found to be extremely low, and the neurologic symptom was considered to be peripheral neuropathic type (dry beriberi), and the circulatory failure was considered to be edema type (wet beriberi), both of the symptoms improved by the vitamin administration.

• Brand Name: PLASMAFLO OP
• Common Device Name: PLASMA SEPARATOR
• Manufacturer (Section D): ASAHI KASEI MEDICAL CO., LTD.; 1-1-2 yurakucho; chiyoda-ku; tokyo 100-0 006; JA 100-0006
• MDR Report Key: 8665756
• Report Number: 8010002-2019-00090
• Device Sequence Number: 11326828
• Product Code: MDP
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P820033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/09/2019

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
• Operator of Device: Health Professional
• Device Model Number: OP-05W
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2019
• Initial Report FDA Received Date: 06/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ACH-SIGMA; HEMODIALYSIS (FB-90UB ECHO); IMMUSORBA TR-350
• Outcome Attributed to Adverse Event: Other
• Patient Age: 42 YR