MAUDE Adverse Event Report: MILTENYI BIOTEC GMBH CRYOMACS FREEZING BAG 500

Model Number N/A

Device Problems Fracture (1260); Leak/Splash (1354)

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

Event Date 11/17/2016

Event Type  malfunction  

Event Description

The customer reported that their bmt technologist was performing a bedside thaw of a cryomacs© freezing sag 500 (cfb) in preparation for infusion.During thawing the cfb leaked out into the secondary bag utilized.This was observed and it was emanated from a compromised product sterility/integrity.The examination of the cfb at customer's site revealed a large fracture on the lower left corner.The customer stated that they were able to transplant the patient with cellular material from a second cfb.Therefore any risk for the patient could be actually ruled out.

• Brand Name: CRYOMACS FREEZING BAG 500
• Type of Device: CRYOMACS FREEZING BAG 500
• 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: 6192744
• MDR Text Key: 62922360
• Report Number: 3005290010-2016-00099
• Device Sequence Number: 1
• Product Code: LPZ
• 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: Replace
• Type of Report: Initial
• Report Date: 12/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/19/2018
• Device Model Number: N/A
• Device Catalogue Number: 200-074-402
• Device Lot Number: 6160119004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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