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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MILTENYI BIOTEC GMBH CLINIMACS® PLUS INSTRUMENT
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MILTENYI BIOTEC GMBH CLINIMACS® PLUS INSTRUMENT Back to Search Results
Model Number N/A
Device Problem Failure to Pump (1502)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Date 06/02/2016
Event Type  malfunction  
Event Description
The customer called the miltenyi biotec (b)(4) hotline and complained about a repeated pump stalled error within a clinimacs plus instrument without any evidence.After the hotline call, the customer was able to finish the cell separation procedure.Therefore any risk for the patient could be ruled out.Process control code: (b)(4).
 
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Brand Name
CLINIMACS® PLUS INSTRUMENT
Type of Device
CLINIMACS® PLUS INSTRUMENT
Manufacturer (Section D)
MILTENYI BIOTEC GMBH
friedrich-ebert-strasse 68
bergisch gladbach, 51429
GM  51429
Manufacturer (Section G)
MILTENYI BIOTEC GMBH
friedrich-ebert-strasse 68
bergisch gladbach, 51429
GM   51429
Manufacturer Contact
nancy johansen
85 hamilton st
cambridge, MA 02139
6172180062
MDR Report Key5765403
MDR Text Key48657464
Report Number3005290010-2016-00075
Device Sequence Number1
Product Code OVG
Combination Product (y/n)N
Reporter Country CodeBE
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other Health Care Professional
Remedial Action Inspection
Type of Report Initial
Report Date 06/30/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/01/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number151-01
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/02/2016
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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