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 Type  malfunction  

Manufacturer Narrative

Miltenyi biotec inc.Initiated a maintenance service on 16th may 2017 which included testing the pump unit movement and tolerances.The results were laid dov/n in service report id #(b)(4).There were no deficiencies found at the time of the service.Furthermore, the cam team of miltenyi biotec inc.Also noted that they provided the customer with an extra tubing set, buffer, reagent and frozen cell sample.As a result, the customer was able to run the mock sample without any errors.Therefore, the complained failure couldn't be confirmed by miltenyi biotec.

Event Description

During elution step of a clinimacs® cd34 enrichment, there was a pump stall error notification on the screen and the product was not expelled into the collection bag.The customer wanted someone to look at the process file and investigate whether there is a risk of this being a re-occurring problem.Date of event is unknown.

• 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: 6589893
• MDR Text Key: 75920082
• Report Number: 3005290010-2017-00019
• 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: 05/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2017
• 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
• Date Manufacturer Received: 04/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1