FENWAL 600ML TRANSFER PACK 4R2023

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-07-11 for FENWAL 600ML TRANSFER PACK 4R2023 manufactured by Fenwal.

Event Text Entries

[4754946] On (b)(6) 2014 at 11:14, bmt lab technologist received into the bmt lab an allo related hpc, marrow cellular therapy product (ctp) harvested (b)(6). The bmt technologist began processing the marrow in preparation for infusion. The product was a low volume marrow of approximately 436ml (recipient only 21kg) and required rbc depletion and volume reduction due to major abo incompatibility. The marrow was dispensed into a fenwal 600ml transfer pack for centrifugation. After centrifugation was complete, the technologist opened the centrifuge to discover that the transfer pack integrity along an approximate 3 1/4 inch length of the right side heat sealed seam had failed and the product emptied into and was contained by the centrifuge bucket. The bmt lab tech performing the marrow processing immediately notified the quality mgmt supv who came to the processing facility to oversee the product rescue process. Medical leadership was notified for collaboration and recommendation of product rescue. The centrifuge bucket was moved to a biological safety cabinet and syringes were utilized to remove the product from the centrifuge bucket. The product was re-dispensed into another transfer pack to complete the processing of the ctp. Microbiology cultures were performed pre-processing and post-processing along with a stat gram stain at the time of the incident. The gram stain cell dose was 5. 26 x 10 8/kg. Post-process cell dose after cell rescue was 3. 26 c 10 8/kg. The requested cell dose was met. Due to the unique nature of the ctp and the medical necessity of preserving the ctp for the designed pt, it was determined by the pt's physician to infuse the product and the pt's family was made aware of the incident. The pt was pre-treated with antibiotics and the product was issued at approximately 5pm on (b)(6) 2014. Per the pt's operative report for the infusion, the pt tolerated the infusion well. Pre and post-process sterility testing results are pending. Pt will be monitored for product engraftment.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3977361
• MDR Report Key: 3977361
• Date Received: 2014-07-11
• Date of Event: 2014-06-27
• Date Facility Aware: 2014-06-27
• Date Reported to FDA: 2014-07-10
• Date Reported to Mfgr: 2014-07-02
• Date Added to Maude: 2014-08-06
• 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: FENWAL
• Generic Name: TRANSFER PACK
• Product Code: KSR
• Date Received: 2014-07-11
• Model Number: 600ML TRANSFER PACK
• Catalog Number: 4R2023
• Lot Number: FA13K12149
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 7 MO
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: FENWAL
• Manufacturer Address: LAKE ZURICH IL US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Other	2014-07-11