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

Model Number CLINIMACS CD34 REAG

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 06/05/2015

Event Type  malfunction  

Manufacturer Narrative

Device code: the separation performance of the clinimac cd34 reagent system was insufficient in regard to cell recovery.Method code: analysis of pacs data.Up to now these data sheets are incomplete.Therefore no clear evaluation can be performed now.

Event Description

The customer complained about low cd34 antigen positive stem cell recovery of about 47% after performing the cell enrichment using the clinimacs cd34 reagent system.40% could neither be found in the cd34 antigen negative cell fraction nor in the target cell fraction.Based on the information provided so far it can be stated that there is no harm for the patient because the procedure went well according to the information of the distributor.(b)(6) hospital, (b)(6), contact person: (b)(6).

• Brand Name: CLINIMACS CD34 REAGENT SYSTEM
• Type of Device: CLINIMACS CD34 REAGENT SYSTEM
• Manufacturer (Section D): MILTENYI BIOTEC GMBH; friedrichebertstrasse 68; bergisch gladbach 51429 ; GM 51429
• Manufacturer (Section G): MILTENYI BIOTEC GMBH; friedrichebertstrasse 68; 51429
• Manufacturer Contact: nancy johansen ; 85 hamilton st.; cambridge, MA 02139 ; 6172180062
• MDR Report Key: 5021167
• MDR Text Key: 24093887
• Report Number: 3005290010-2015-00003
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Biomedical Engineer
• Report Date: 07/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CLINIMACS CD34 REAG
• Device Catalogue Number: 171-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/09/2015
• 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