MAUDE Adverse Event Report: MILTENYI BIOTEC GMBH CLINIMACS CD34 REAGENT SYSTEM

Catalog Number	151-01
Medical Device Problem Code	Device Issue (2379)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/10/2015
Type of Reportable Event	Malfunction
Event or Problem Description
The customer complained that the recovery of cd34+ cells was low (about 20%) for a separation procedure.Also, re-labeling and re-selection of the negative fraction (after overnight storage) was not successful.This event occurred at: (b)(6).

• Brand Name: CLINIMACS CD34 REAGENT SYSTEM
• Common Device Name: CLINIMACS CD34 REAGENT SYSTEM
• Manufacturer (Section D): MILTENYI BIOTEC GMBH; friedrich-ebert-strasse 68; bergisch gladbach, 51429 ; GM 51429
• MDR Report Key: 5367492
• Report Number: 3005290010-2016-00041
• Device Sequence Number: 10865789
• Product Code: OVG
• UDI-Device Identifier: 04049934004827
• UDI-Public: 04049934004827
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: BH110018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Report Date (Section B): 01/08/2016

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 Catalogue Number: 151-01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/14/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1