MAUDE Adverse Event Report: MILTENYI BIOTEC GMBH CLINIMACS CD34 REAGENT

Model Number	N/A
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/11/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Miltenyi biotec (b)(4) has handed over an investigation questionnaire to the customer to obtain more details about the complained clinimacs® cell separation.Based on the entire data and the facs plots of the positive fraction received, following results can be ascertained: the source product for the selection procedure was a fresh, mobilized leukapheresis product containing 27xl0e9 tnc and 76,8xl0e6 cd34-cells (= 0,28% cd34+).The separation was performed with one vial of clinimacs® cd34 reagent, clinimacs® tubing set and cd34 selection!-program.Igg was added prior labeling for blocking of unspecific binding sites.Small aggregates were observed in the original fraction positive fraction: viability was 94% cd34+ recovery was indeed 31 % purity was 94% results #: the selection procedure has been performed inside the specifications of the clinimacs® cd34 reagent and the respective tubing set.The plt-wash was not exactly done at a 1:3 dilution.By using a lower amount of buffer, the platelet removal might not have been sufficient with potential consequence of weak labeling and loss of cd34+-cells.
Event or Problem Description
The customer complained that the recovery of cd34+-cells was low (3.3%) for a clinimacs separation procedure.

• Brand Name: CLINIMACS CD34 REAGENT
• Common Device Name: CLINIMACS CD34 REAGENT
• Manufacturer (Section D): MILTENYI BIOTEC GMBH; friedrich-ebert-strasse 68; bergisch gladbach, 51429 ; GM 51429
• MDR Report Key: 5634846
• Report Number: 3005290010-2016-00065
• Device Sequence Number: 18905379
• Product Code: OVG
• UDI-Device Identifier: 04049934004827
• UDI-Public: 04049934004827
• Combination Product (Y/N): N
• Initial Reporter Country: MU
• PMA/510(K) Number: BK090020
• 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): 05/04/2016

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 Model Number: N/A
• Device Catalogue Number: 171-01
• Device Lot Number: 6151218004
• 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: 05/05/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1