MAUDE Adverse Event Report: MILTENYI BIOTEC GMBH CLINIMACS PLUS INSTRUMENT

Model Number N/A

Device Problem Failure to Pump (1502)

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

Event Date 12/20/2016

Event Type  malfunction  

Event Description

The customer complained on a clinimacs plus instrument due to incomplete sample loading caused by a pump stall error.They were able to finish the cell separation manually and rescued the cells.No risk for any patient.

• 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 Key: 6258027
• MDR Text Key: 65029133
• Report Number: 3005290010-2017-00103
• Device Sequence Number: 1
• Product Code: OVG
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: Repair
• Type of Report: Initial
• Report Date: 01/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2017
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2016
• 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