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

Model Number N/A

Device Problems Break (1069); Leak/Splash (1354)

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

Event Date 11/30/2016

Event Type  malfunction  

Event Description

The customer complained on a leaking tubing of a cryom&cs® freezing bag 500 when cellular material was filled in the bag prior to freezing.To minimize the possibility of further contamination, the product (73 ml out of 360 ml) was immediately transferred to a new freezing bag and subjected to automated freezing procedure accordingly.The possible impact to the patient intended for stem cell transplantation is currently under review according to the customer's description.The customer sent photographs for a preliminary investigation.The affected freezing bag was also sent to miltenyi biotec (b)(4) but not yet arrived.

• 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: 6199778
• MDR Text Key: 63207012
• Report Number: 3005290010-2016-00101
• Device Sequence Number: 1
• Product Code: LPZ
• 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: Replace
• Type of Report: Initial
• Report Date: 12/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2016
• 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: 12/01/2016
• 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
• Patient Outcome(s): Congenital Anomaly