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

Model Number	70103
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/26/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a low recovery (30%) and purity (60%) for a cd34 separation in an autologous setting for a neuroblastoma patient.Nothing out of the ordinary was observed during the separation run.Also the volume of the target fraction was as expected.The number of target cells in the starting material was low with 1.8x106 cd34 positive cells.The patient was not treated with the product.An investigation concluded that there is no hint for a product malfunction or user error but that rather the composition and characteristics of this starting material lead to the dissatisfying results.The frequency of cd34+ cells in the starting material was very low and the material was derived from a pre-treated patient.

• 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: 9852809
• Report Number: 3005290010-2020-00010
• Device Sequence Number: 14119208
• Product Code: OVG
• UDI-Device Identifier: 04049934004827
• UDI-Public: 04049934004827
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/18/2020

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 Expiration Date: 07/03/2020
• Device Model Number: 70103
• Device Catalogue Number: 200-070-100
• Device Lot Number: 6190807009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2020
• Initial Report FDA Received Date: 03/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1