MAUDE Adverse Event Report: MILTENYI BIOTEC GMBH CLINIMACS PLUS INSTRUMENT; ICLINIMACS PLUS INSTRUMENT

Model Number	N/A
Medical Device Problem Code	Device Stops Intermittently (1599)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	04/21/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not returned to the manufacturer.
Event or Problem Description
Approx.20 min into the program, the instrument displayed an error."pump error: pump door open" even though the operator did not adjust the clinimacs plus instrument, the pump door was close and tubing was threaded properly.The program gave the operator approx.300 sec to response the issue.After 300 sec, the run was automatically aborted by the clinimacs plus instrument.An emergency elution was performed.The unprocessed product volume was transferred to the recovered elution and a second run was performed with a new kit.Therefore, the cellular material could be rescued and any risk for the patient could be ruled out.

• Brand Name: CLINIMACS PLUS INSTRUMENT
• Common Device Name: ICLINIMACS PLUS INSTRUMENT
• Manufacturer (Section D): MILTENYI BIOTEC GMBH; friedrich-ebert-strasse 68; bergisch gladbach, 51429 ; GM 51429
• MDR Report Key: 5671282
• Report Number: 3005290010-2016-00070
• Device Sequence Number: 49381
• Product Code: OVG
• UDI-Device Identifier: 04049934004841
• UDI-Public: 04049934004841
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: BH110018
• 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: Other,Repair
• Type of Report: Initial
• Report Date (Section B): 05/20/2016

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 Model Number: N/A
• Device Catalogue Number: 151-01
• Device Lot Number: NOT KNOWN
• 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: 05/23/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1