MAUDE Adverse Event Report: MILTENYI BIOTEC GMBH CLINIMACS CD34 REAGENT

Catalog Number 200-070-100

Device Problem Insufficient Information (3190)

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

Event Date 08/27/2019

Event Type  malfunction  

Event 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
• Type of Device: CLINIMACS CD34 REAGENT
• Manufacturer (Section D): MILTENYI BIOTEC GMBH; friedrich-ebert-str. 68; bergisch gladbach, 51429 ; GM 51429
• Manufacturer (Section G): MILTENYI BIOTEC GMBH; 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: 9098156
• MDR Text Key: 191916832
• Report Number: 3005290010-2019-00004
• Device Sequence Number: 1
• Product Code: OVG
• UDI-Device Identifier: 04049934004827
• UDI-Public: 04049934004827
• Combination Product (y/n): N
• Reporter Country Code: IS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/07/2020
• 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: 08/27/2019
• 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
• Patient Outcome(s): Other