MAUDE Adverse Event Report: MILTENYI BIOTEC B.V. & CO. KG CLINIMACS CD34 REAGENT

Model Number	70103
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/12/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The customer complained a low elution volume and low recovery of a cd34 separation.The patient could not be treated.To our information it was considered to re-collect the donor to repeat the cd34 separation.As the customer did not provide the lot number of the reagent, a complaint rate could not be calculated.However, such incidents are very rare.An analysis of the process code showed that the process was finished without error codes.However, the sample loading time was unusually high and the volumes after separation did not fit the expected range.The customer indicated that the fluid pathway might have been partially blocked.This explains or at least contributed to the low volume and low recovery.The high loading time is probably due to sample material older than recommended and validated (41h vs.24h).This increases the risk for aggregates what again has influence on the elution volume and recovery.

• Brand Name: CLINIMACS CD34 REAGENT
• Common Device Name: CLINIMACS CD34 REAGENT
• Manufacturer (Section D): MILTENYI BIOTEC B.V. & CO. KG; friedrich-ebert-str. 68; bergisch gladbach, 51429 ; GM 51429
• MDR Report Key: 10245050
• Report Number: 3005290010-2020-00014
• Device Sequence Number: 594401
• Product Code: OVG
• UDI-Device Identifier: 04049934004827
• UDI-Public: 04049934004827
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 70103
• Device Catalogue Number: 200-070-103
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2020
• Initial Report FDA Received Date: 07/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1