MAUDE Adverse Event Report: MILTENYI BIOTEC GMBH CLINIMACS CD34 REAGENT SYSTEM; CLINIMACS TUBING SET LS

Model Number	N/A
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	04/26/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not returned to the manfuacturer.
Event or Problem Description
A clinimacs® cd34 selection has been performed by the customer.In total 76.4xl0e9 wbc (white blood cells) including 1.8xl0e9 cd34 cells have been processed using one vial of clinimacs® cd34 reagent and the enrichment program selection 1 applying the clinimacs® tubing set.The cd34 yield after the selection was low.The customer stated that they used another tubing set to separate the cd34+ cells from the negative fraction bag.Therefore any risk for the patient could be ruled out.

• Brand Name: CLINIMACS CD34 REAGENT SYSTEM
• Common Device Name: CLINIMACS TUBING SET LS
• Manufacturer (Section D): MILTENYI BIOTEC GMBH; friedrich-ebert-strasse 68; bergisch gladbach, 51429 ; GM 51429
• MDR Report Key: 5671276
• Report Number: 3005290010-2016-00069
• Device Sequence Number: 174250
• Product Code: OVG
• UDI-Device Identifier: 04049934004841
• UDI-Public: 04049934004841
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: BH110018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 05/20/2016

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 Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: NOT KNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2016
• Initial Report FDA Received Date: 05/23/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1