MAUDE Adverse Event Report: MILTENYI BIOTEC GMBH CLINIMACS PLUS INSTRUMENT

Model Number N/A

Device Problems Failure to Pump (1502); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Clinimacs cd3/cd19 depletion runs were performed on two different clinimacs plus instruments.The instruments stopped mistream, saying process aborted.After the customer had pressed the "enter" button, the machines provided a process code.

• 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 ; 120 beacon st; suite 200; somerville, MA 02143 ; 6172180062
• MDR Report Key: 6847184
• MDR Text Key: 86574877
• Report Number: 3005290010-2017-00020
• Device Sequence Number: 1
• Product Code: OVG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 09/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 151-01
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1