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

Model Number FREEZING BAG 500

Device Problem Use of Device Problem (1670)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Method: device not returned, method consisted of analysis of cryomacs complaint questionnaire with detailed thawing description.Results of the investigation are attached to this mdr.

Event Description

The customer reported that the overwrap bags of three cryomacs freezing bags 500 were swelling up on the third day of freezing and thus the bags could not be taken out of the cassette used for storage in the vapor phase of liquid nitrogen.Based on the information provided so far it is unclear whether or not the patient received sufficient cell amount.Therefore a potential harm for the patient cannot be ruled out at this time point.The event happened at (b)(6).

• Brand Name: CRYOMACS FREEZING BAG 500
• Type of Device: CRYOMACS FREEZING BAG 500
• Manufacturer (Section D): MILTENYI BIOTEC GMBH; friedrichebertstrasse 68; bergisch gladbach 51429 ; GM 51429
• Manufacturer (Section G): MILTENYI BIOTEC GMBH; friedrichebertstrasse 68
• Manufacturer Contact: nancy johansen ; 85 hamilton st; cambridge, MA 02139 ; 6172180062
• MDR Report Key: 4964921
• MDR Text Key: 23475467
• Report Number: 3005290010-2015-00002
• Device Sequence Number: 1
• Product Code: KSR
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: BK090020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Not Applicable
• Report Date: 06/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2015
• Device Model Number: FREEZING BAG 500
• Device Catalogue Number: 200-074-402
• Device Lot Number: 6120924008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1