MAUDE Adverse Event Report: MILTENYI BIOTEC GMBH CLINIMACS CD34 REAGENT

Catalog Number	200-070-100
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/27/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Customer performed an autologous cd34 enrichment with low number of cd34 cells in beginning (42x10e6) from total 2.4x10e10 wbcs.Process control code was fine.The target obtained 11.4x10e8 total cells with only a cd34 purity of 1%.This is in total 11.8x10e6 cd34 cells and a cd34 yield of 28%.Both, the purity and yield does not match the customers and patients need.Finally, the patient was not treated with an experimental treatment.No more information on the patient was provided by the customer.The investigation revealed a suboptimal starting material with a very low frequency of stem cells and a low total number of cells.This has a huge influence on the performance.Important data to fully understand the case were not delivered by the customer (analysis of waste fraction).

• Brand Name: CLINIMACS CD34 REAGENT
• Common Device Name: CLINIMACS CD34 REAGENT
• Manufacturer (Section D): MILTENYI BIOTEC GMBH; friedrich-ebert-str. 68; bergisch gladbach, 51429 ; GM 51429
• MDR Report Key: 9098156
• Report Number: 3005290010-2019-00004
• Device Sequence Number: 2158141
• Product Code: OVG
• UDI-Device Identifier: 04049934004827
• UDI-Public: 04049934004827
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/20/2019

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: 01/07/2020
• 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: 08/27/2019
• Initial Report FDA Received Date: 09/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other