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

Model Number PE-08

Device Problem No Apparent Adverse Event (3189)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 04/10/2020

Event Type  Injury  

Event Description

This event occurred during plasma exchange therapy using plasmacure pe in china on (b)(6) 2020.Plasmcure pe is identical model to op-05w(a) marketed in us.Although the time elapsed after the start of treatment is unknown, the patient experienced sudden hypotension, palpitations, and chest tightness at 11:05.Plasma exchange therapy was discontinued, sodium chloride injection was administered intravenously, and vasopressor treatment of atropine sulfate hydrate, epinephrine, and dopamine hydrochloride were given.At 11:30, the symptoms were relieved and vital signs were stabilized.

Manufacturer Narrative

The product of this event was not returned to the manufacturer and could not be analyzed; however, we investigated manufacturing and quality control records based on the lot number.According to the investigation, no potential for malfunction was found and no similar event has been reported with this lot number globally so far.The physician determined, this event as "serious injury" and the causal relationship between hypotension and the use of the medical device cannot be denied.We determined to report this incident since we also consider blood pressure decreased as "serious injury" and the causal relationship between hypotension and the use of the medical device cannot be denied.Hypotension is described as one of the adverse events in "e.Precautions" of ifu.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.; 2111-2 oaza sato; oita-shi; oita, 870-0 396; JA 870-0396
• Manufacturer Contact: ms. kagami ; 1-1-2 yurakucho; chiyoda-ku; tokyo, 100-0-006 ; JA 100-0006
• MDR Report Key: 17753389
• MDR Text Key: 323470857
• Report Number: 8010002-2023-00030
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: PE-08
• Device Lot Number: NJ5B5N
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 38 YR
• Patient Sex: Female