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

Model Number 70103

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 02/26/2020

Event Type  malfunction  

Event 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
• Type of Device: CLINIMACS CD34 REAGENT
• Manufacturer (Section D): MILTENYI BIOTEC B.V. & CO. KG; friedrich-ebert-str. 68; bergisch gladbach, 51429 ; GM 51429
• Manufacturer (Section G): MILTENYI BIOTEC B.V. & CO. KG; friedrich-ebert-str. 68; bergisch gladbach, 51429 ; GM 51429
• Manufacturer Contact: bettina-judith höhlich ; friedrich-ebert-str. 68; bergisch gladbach, 51429 ; GM 51429
• MDR Report Key: 9852809
• MDR Text Key: 191917569
• Report Number: 3005290010-2020-00010
• Device Sequence Number: 1
• Product Code: OVG
• UDI-Device Identifier: 04049934004827
• UDI-Public: 04049934004827
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2020
• 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