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

Model Number OP-05(A)

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/03/2018

Event Type  malfunction  

Manufacturer Narrative

This incident, "leakage from the arterial connector through the small crack" happened in germany, and was noticed by the nurse, just after the treatment started.We are reporting this incident to fda according to the requirement.Plasmaflo op-05w(l) is similar model of plasmaflo op-05w(a) marketed in us.The used device could not analysed because it was discarded by the user facility.We investigated the manufacturing and quality control records of the lot number and no abnormality was found.Furthermore, no similar complaint was reported by other facilities at this moment.Consequently, the root cause of the event could not be identified as only the insufficient information was available.The caution for "blood leakage" is described in precautions of the package insert as 14.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.; leakage in the membrane or the extracorporeal circuit.We decided to report this incident since we consider blood leakage from the arterial connector is an incident which might cause serious injury to the patient.We understand the importance of quality control, and we assure you that we will continue to investigate all possible methods for improving the quality of our products, and to be vigilant for the trend in occurring this kind of incident.

Event Description

On (b)(6) 2018: just after starting the treatment with apheresis session of op-05w(l), the nurse realized that the blood was dripping out of its arterial connector, where its small crack was found.After the filter was changed to new one, the treatment was continued.Priming and rinsing volume: 2,000ml respectively, qb 100ml/min., qf 30ml/min.No adverse event was reported.

• Brand Name: PLASMAFLO OP
• Type of Device: PLASMA SEPARATOR
• Manufacturer (Section D): ASAHI KASEI MEDICAL CO., LTD.; 1-105, kanda jinbocho; chiyoda-ku; tokyo, 101-8 101; JA 101-8101
• 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 ; 1-105, kanda jinbocho; chiyoda-ku; tokyo 101-8-101 ; JA 101-8101
• MDR Report Key: 7636738
• MDR Text Key: 112855243
• Report Number: 8010002-2018-00120
• Device Sequence Number: 1
• Product Code: MDP
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P820033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: OP-05(A)
• Device Catalogue Number: N/A
• Device Lot Number: GG2K33
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2017
• 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