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

Model Number OP-08W

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

Patient Problems Dyspnea (1816); Breast Discomfort/Pain (4504)

Event Date 11/21/2021

Event Type  Death  

Event Description

This incident occurred in (b)(6) on (b)(6) 2021.14:10 the double filtration plasma apheresis (dfpp) treatment was started using plasmafloop-08w which is similar product of plasmaflo op-05w(a) marketed in us, and cascadeflo ec-30w which separates substances in a certain molecular weight region from separated plasma and is not marketed in us.14:34.The blood purification system issued a hemolysis alarm.Membrane damage was suspected and the treatment was stopped immediately.15:43 the treatment was resumed after replacing the op-08w, ec-30w and blood circuit with new ones.16:15 the patient suddenly developed chest tightness, shortness of breath and sweating.Treatment was stopped immediately, and dexamethasone 5 mg was administered intravenously.Urine was alkalized by intravenous administration of nahco3.At the same time, laboratory test was performed.19:59 the patient died without recovery.The details of the cause of death are unknown.

Manufacturer Narrative

Survey of the returned product: as a result of analyzing the returned product, no abnormality was found.Survey results of manufacturing records: the manufacturing and shipping records of the lot were confirmed, but no abnormalities were found.Physician's comment: according to the interview with the physician, leakage of plasmaflo op-08w causes hemolysis, which may result in blood loss-related death, but it was judged that the causal relationship cannot be denied based on the information currently.Company's comment: the doctor considers that hemolysis due to an abnormality in the membrane of the first op may be involved in death, but as a result of analyzing the first and second ops, abnormalities were not found.Therefore, it is unlikely that hemolysis that occurred during treatment with the first op was the direct cause of death.However, since these symptoms occurred while using the second op and the patient died without recovery, the causal relationship between the death and the use of the first or second op cannot be denied and we submit this report.Although no information on the cause of death was obtained, anti-neutrophil cytoplasmic antibody positive vasculitis, acute glomerulonephritis, nephrogenic anemia, and lung infection are the primary diseases of this patient, and it is highly possible that these are the causes.It is described in e.Precautions of the instruction for use as follows.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.If any problem such as the following occurs during treatment with the plasmaflo¿ op-05w(a), immediately ensure the safety of the patient and take appropriate measures, such as discontinuation of the treatment or replacement of the plasmaflo¿ op-05w(a), in accordance with the directions of the responsible physician.We will continue to monitor the occurrence of similar events carefully.

• 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: 12982351
• MDR Text Key: 282090505
• Report Number: 8010002-2021-00080
• Device Sequence Number: 1
• Product Code: MDP
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 11/23/2021

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 Expiration Date: 02/29/2024
• Device Model Number: OP-08W
• Device Lot Number: ZL393G AND ZL2Q36
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2021
• Initial Date FDA Received: 12/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2021
• 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): Death
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 52 KG