MAUDE Adverse Event Report: MILTENYI BIOTEC GMBH CLINIMACS TUBING SET

Catalog Number	161-01
Medical Device Problem Code	Device Issue (2379)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/10/2016
Type of Reportable Event	Malfunction
Event or Problem Description
No sample loading by clinimacs plus tubing set was complained by the customer.

• Brand Name: CLINIMACS TUBING SET
• Common Device Name: CLINIMACS TUBING SET
• Manufacturer (Section D): MILTENYI BIOTEC GMBH; friedrich-ebert-strasse 68; bergisch gladbach, 51429 ; GM 51429
• MDR Report Key: 5480714
• Report Number: 3005290010-2016-00052
• Device Sequence Number: 13676983
• Product Code: OVG
• UDI-Device Identifier: 04049934004841
• UDI-Public: 04049934004841
• 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: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 03/04/2016

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 Catalogue Number: 161-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2016
• Initial Report FDA Received Date: 03/04/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1