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U.S. Department of Health and Human Services

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

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ASAHI KASEI MEDICAL CO., LTD. PLASMAFLO OP; PLASMA SEPARATOR Back to Search Results
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.
 
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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 Key12982351
MDR Text Key282090505
Report Number8010002-2021-00080
Device Sequence Number1
Product Code MDP
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P820033
Number of Events Reported1
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 Date02/29/2024
Device Model NumberOP-08W
Device Lot NumberZL393G AND ZL2Q36
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/24/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/23/2021
Initial Date FDA Received12/13/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/06/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age81 YR
Patient SexMale
Patient Weight52 KG
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