CRYOMACS FREEZING BAG 500

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-19 for CRYOMACS FREEZING BAG 500 manufactured by Mittenyi Biotec Inc..

Event Text Entries

[64073665] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5066824
• MDR Report Key: 6193359
• Date Received: 2016-12-19
• Date of Report: 2016-12-19
• Date of Event: 2016-11-17
• Date Added to Maude: 2016-12-21
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: CRYOMACS FREEZING BAG 500
• Generic Name: CRYOMACS FREEZING BAG 500
• Product Code: KSR
• Date Received: 2016-12-19
• Model Number: CRYOMACS FREEZING BAG 500
• Lot Number: 6160119004
• Device Expiration Date: 2018-12-19
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MITTENYI BIOTEC INC.
• Manufacturer Address: BERGISCH GLADBACH NORTH RHINE-WESTPHALIA 51429 GM 51429

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2016-12-19