MILTENYI CRYOMACS FREEZING BAG 500 FREEZE BAG 500 200-074-402

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-09-03 for MILTENYI CRYOMACS FREEZING BAG 500 FREEZE BAG 500 200-074-402 manufactured by Miltenyi Biotec.

Event Text Entries

[4730254] Infusion of cryopreserved autologous hpc, apheresis cellular therapy product (ctp) was scheduled for (b)(6) 2014. Three cryopreserved product bags were released from the stem cell lab and distributed to the pt bedside for infusion. Thaw and admin of the first and third units was performed without incident. Upon thaw of the second unit, leakage of the product into the secondary thawing bag was noted by the technologist performing the thaw. The technologist immediately identified the source of the leak and clamped the affected area. The leakage occurred at the base of the attached tubing (utilized for dispensing product/reagents into the cryo bag) just below where the tubing is heat sealed by the technologists at the completion of precessing. The integrity failure occurred at this location of the tubing where the tubing welds to the parent container and broke off at this area of the tubing. A 10 ml of product was lost as a result of the leakage. Due to medical necessity, it was determined by medical staff to infuse the product. Blood cultures were drawn on the pt and finalized on (b)(6) 2014 as "no growth". Post-thaw sterility samples were obtained from the affected product and sent for sterility testing. The post-thaw sterility testing was finalizing on (b)(6) 2014 as "no growth 14 days". Despite the product leakage, the pt received an optimal cd34+ cell dose. Per the pt operative report, the pt tolerated the procedure well and there were no expected and/or unexpected adverse reactions related to the product infusion.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 4055724
• MDR Report Key: 4055724
• Date Received: 2014-09-03
• Date of Report: 2014-08-07
• Date of Event: 2014-07-25
• Date Facility Aware: 2014-07-25
• Report Date: 2014-08-11
• Date Reported to Mfgr: 2014-08-07
• Date Added to Maude: 2014-09-05
• Event Key: 0
• Report Source Code: User Facility 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: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MILTENYI CRYOMACS FREEZING BAG 500
• Generic Name: CRYOPRESERVATION FREEZE BAG
• Product Code: KSR
• Date Received: 2014-09-03
• Model Number: FREEZE BAG 500
• Catalog Number: 200-074-402
• Lot Number: 6130206003
• Device Expiration Date: 2016-02-01
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 4 MO
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MILTENYI BIOTEC
• Manufacturer Address: BERGISCH GLADBACH GM

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2014-09-03