MAUDE Adverse Event Report: MILTENYI BIOTEC GMBH CLINIMACS PLUS INSTRUMENT

Catalog Number	151-01
Medical Device Problem Code	Device Issue (2379)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
I has requested the process details as well as hardcopies of the performed flow cyometric alalysis data.The clinimacs plus instrument itself was not sent back to miltenyi for further investigation.Results: two applicable root causes have been identified which either alone or in combination do explain the observed deteriorate product viability after the clinimacs cd34 separation.
Event or Problem Description
The customer performed a large scale clinimacs cd34 enrichment procedure with mobilized apheresis product consisting of 8.3x10e10 total wbcs.After the enrichment process, the target fraction was analyzed by flow cytometry and approx 38% of the cells had been found 7aad positive, i.E.Either apototic or dead.Process code: 510g0o00s8o02y0.This event occurred at: hamatology, oncology & immunology, baldinger str.(b)(4).

• Brand Name: CLINIMACS PLUS INSTRUMENT
• Common Device Name: CLINIMACS PLUS INSTRUMENT
• Manufacturer (Section D): MILTENYI BIOTEC GMBH; friedrich-ebert-strasse 68; bergisch gladbach, 51429 ; GM 51429
• MDR Report Key: 5431271
• Report Number: 3005290010-2016-00045
• Device Sequence Number: 505500
• Product Code: OVG
• UDI-Device Identifier: 04049934004636
• UDI-Public: 4049934004636
• 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: Notification
• Type of Report: Initial
• Report Date (Section B): 02/11/2016

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/11/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1