MAUDE Adverse Event Report: MITTENYI BIOTEC INC. CRYOMACS FREEZING BAG 500

Model Number CRYOMACS FREEZING BAG 500

Device Problems Fluid/Blood Leak (1250); Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Date 11/17/2016

Event Type  malfunction  

Event Description

Autologous hpc, apheresis cellular therapy product (ctp) infusion was scheduled for (b)(6) 2016.On (b)(6) 2016 after verifying the product labeling and integrity the bmt laboratory technologists transferred half of the patient' s ctp from long term liquid nitrogen (ln2) storage to an appropriate dry shipper for transport to the patient bedside for thaw and infusion.The bmt laboratory technologist removed the first bag from the dry shipper, verified the product labeling/integrity, and thawed the first bag without incident.The product was infused per protocol.The bmt laboratory technologist proceeded to remove the second bag from the dry shipper and verified the product labeling/integrity with no variances noted.Upon thawing of the second ctp bag with (b)(4), leakage of the product into the secondary zip lock bag containing the freeze bag and its contents was observed.Further examination of the freeze bag revealed a fracture of the base of the bag in the lower left corner.The nurse infusionist was immediately made aware of the fracture and leakage and proceeded to notify the attending physician of the findings.Due to the compromised integrity and sterility of the ctp, the attending physician determined not to initiate any cell product rescue procedures.An alternate and intact freeze bag from the same day's cell collection ((b)(4)) was substituted for the fractured bag for infusion and was thawed and infused without incident.

• Brand Name: CRYOMACS FREEZING BAG 500
• Type of Device: CRYOMACS FREEZING BAG 500
• Manufacturer (Section D): MITTENYI BIOTEC INC. ; bergisch gladbach; north rhine-westphalia 51429 ; GM 51429
• MDR Report Key: 6193359
• MDR Text Key: 64073665
• Report Number: MW5066824
• Device Sequence Number: 1
• Product Code: KSR
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• 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: 12/19/2016
• 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: CRYOMACS FREEZING BAG 500
• Device Lot Number: 6160119004
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Weight: 83