MAUDE Adverse Event Report: MILTENYI BIOTEC GMBH CLINIMACS PLUS INSTRUMENT

Catalog Number	151-01
Medical Device Problem Code	Device Difficult to Maintain (3134)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/27/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device difficult to maintain - customer does not have preventive maintenance contract with miltenyi, the machine is very old, therefore difficult to maintain without routine maintenance.Process evaluation - miltenyi biotec service group has sent the customer a quote for service and is waiting for approval from customer.Service has quote out to customer.
Event or Problem Description
The customer received an error message #12 on their clinimacs plus instrument (b)(4)after the sample had been loaded.The operator was not next to the instrument when the error appeared, however, the negative fraction had already been eluted.No fluid/cells had been eluted into the positive fraction.Error 12 reads magnet error - refer to manual.Miltenyi technical service was called immediately and guided the customer through 2 emergency procedures.They were able to rescue cells, therefore no harm was caused to the patient.

• 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: 5540901
• Report Number: 3005290010-2016-00061
• Device Sequence Number: 10837969
• Product Code: OVG
• UDI-Device Identifier: 04049934004636
• UDI-Public: 4049934004636
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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): 04/01/2016

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 Catalogue Number: 151-01
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/01/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1