MAUDE Adverse Event Report: MILTENYI BIOTEC GMBH CLINIMACS CD34 SYSTEM

Lot Number	6151218004
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/28/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Miltenyi biotec has given customer questionnaire in order to obtain further information of the event and details about the cell separation.The source product shows high number of platelets and during platelet wash only 39% of platelets were depleted.Insufficient platelet depletion may lead to suboptimal labeling conditions.As contaminating cells in the positive fraction were apparently mainly b cells and monocytes most probably this was due to unspecific binding of the cd34 reagent via fc receptors.
Event or Problem Description
The customer complained that the purity of cd34+ cells was low (94%) for a separation procedure using the clinimacs cd34 system.The user decided to use the product because most t cells are found in the negative fraction.There was no risk to patient.This event occurred at: (b)(6).

• Brand Name: CLINIMACS CD34 SYSTEM
• Common Device Name: CLINIMACS CD34 SYSTEM
• Manufacturer (Section D): MILTENYI BIOTEC GMBH; friedrich-ebert-strasse 68; bergisch gladbach, 51429 ; GM 51429
• MDR Report Key: 5469984
• Report Number: 3005290010-2016-00048
• Device Sequence Number: 16385205
• Product Code: OVG
• UDI-Device Identifier: 04049934004827
• UDI-Public: 04049934004827
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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: Notification
• Type of Report: Initial
• Report Date (Section B): 03/01/2016

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 Expiration Date: 05/18/2016
• Device Lot Number: 6151218004
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/01/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1