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

Model Number OP-08W(L)

Device Problem Biocompatibility (2886)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 11/26/2019

Event Type  Injury  

Manufacturer Narrative

The used device has not been analyzed since it could not be obtained from the customer.In addition, we could not investigate manufacturing and quality control records based on the lot number since it is unknown.The event is considered an allergic reaction and the customer commented that the patient could only be triggered by eating a ham, butter and cheese sandwich a few minutes before the development of pruritus on (b)(6).The treatment method will be changed to immuno-adsorption from the next treatment.We considered that this incident serious since the patient's systolic blood pressure dropped to 70 mmhg, and that the causal relationship could not be denied since the symptom appeared during treatment.Hypotonia is described in warning of the instructions for use as "monitor the patient constantly during treatment with the plasmaflo op.In the event of any of the following (hypotonia) during treatment, immediately ensure the safety of the patient and take appropriate measures in accordance with the directions of the responsible physician.We will continue to monitor similar complaints carefully.

Event Description

The patient's primary disease is hypercholesterolemia due to a homozygous variant of ldl cholesterol, which has been treated with ldl apheresis since she was (b)(6) years old.The facility has been implementing the double filtration plasmapheresis for the patient since 2015.On (b)(6) 2019, the patient was treated with plasmaflo op-08w(l) and cascadeflo ec.She suffered from pruritus, especially on the scalp 120 minutes after the start of treatment.The pruritus was associated with infiltrated macular rash located in the hair, the forehead, the cheeks and the neck.These symptoms were associated with a tingling sensation, followed by noticeable angioedema on both the lips and tongue without dyspnea and bronchospasm.The ige value was 336 ui / l, and tryptase was normal both at the time of the event and 30 minutes after the event.Compared to the previous treatment, there was no change in the treatment protocol.The patient's medication did not change, either.These events were treated with polaramine and adrenaline.The ldl treatment has been stopped and the patient stayed the whole day at the hospital for follow-up.Since the symptoms did not recur, cetirizine was prescribed at 10 mg/day for 10 days and she went back home.On (b)(6) 2019, the patient was treated with plasmaflo op-08w(l) and cascadeflo ec.75 minutes after the start of treatment, she suffered from facial and chest erythroses, pruritus, followed by hives and tongue angioedema and then the treatment was discontinued.The ige value was 369 ui / l, and the tryptase value was normal.On (b)(6) 2019, the patient was treated with plasmaflo op-08w(l) and rheofilter er.Cascadeflo ec was changed to rheofilter er and the patient was pre-administered with polaramine before treatment.90 minutes after the start of treatment, rash occurred and systolic blood pressure dropped to 70 mmhg, therefore treatment was discontinued.Plasmaflo op-08w(l) is a plasma separator which is similar product of plasmaflo op-05w(a) marketed in us.

• Brand Name: PLASMAFLO OP
• Type of Device: PLASMA SEPARATOR, PRODUCT CODE: MDP
• 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: akitake yamashita ; 1-1-2 yurakucho; chiyoda-ku; tokyo, 100-0-006 ; JA 100-0006
• MDR Report Key: 9514577
• MDR Text Key: 181582590
• Report Number: 8010002-2019-00150
• Device Sequence Number: 1
• Product Code: MDP
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OP-08W(L)
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2019
• 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 Age: 24 YR
• Patient Weight: 59