MAUDE Adverse Event Report: PALL CORPORATION PALL MEDICAL; CELL WASH/INFUSION SET

Catalog Number 791-03

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293); Device Disinfection Or Sterilization Issue (2909); Material Integrity Problem (2978)

Patient Problem No Information (3190)

Event Date 03/30/2016

Event Type  malfunction  

Event Description

(b)(4) laboratory technologists performed a cell wash procedure for an unrelated allogeneic hpc, cord blood unit on (b)(6) 2016 in preparation for distribution of the washed product for infusion into a recipient at (b)(6).After completing centrifugation of the product as required by the wash protocol, the technologists removed the centrifuge bucket from the centrifuge.Upon visually inspecting the cell wash/infusion bag of the wash set residing in the centrifuge bucket support insert, it was determined that fluid had leaked from the cell wash/infusion bag and was being contained in the support insert.(b)(4) laboratory technologists immediately notified the quality management supervisor and quality coordinator of the findings.The quality management supervisor and quality control coordinator went to the clean room facility to assist in assessing the incident.Visual examination of the cell wash/infusion bag revealed a very small pin hole at the base of the cell wash/infusion bag above the heat seal.On visual inspection, it does not appear that the heat seal is involved.As a result of the pin hole, approx 5ml of the product with a tnc of 2.17 x 10.7 was lost.Measures were initiated for cellular product rescue and wash of the remaining product using dextran was completed.Cellular product rescue resulted in a tnc recovery of 93 x 10.7 resulting in a tnc cell dose for infusion of 11.63 x 10.7/kg.As a result of the cell wash/infusion bag integrity failure, the sterility of the unit was compromised.After review of the findings and due to the medical necessity, it was determined by the patient's transplant physician to infuse the product.The product was infused on (b)(6) 3016 without incident.Sterility testing results are pending as of the date of this report 04/06/2016.

Event Description

Add'l info received on july 18, 2016 for report mw5061646.On (b)(6) 2016, bmt lab technologist performed a cell wash procedure for an unrelated allogeneic hpc, cord blood unit for infusion into the designated recipient.A cell wash/infusion set integrity failure occurred during centrifugation and was reported to pall medical on (b)(6) 2016.Voluntary medwatch report (#(b)(4)) was submitted.In this incident, a very small pin hole was noted at the base of the bag compromising the sterility of the product.The cord blood unit (cbu) failed to engraft.A second cbu was requested for wash and infusion into the same pt.On (b)(6) 2016, bmt lab technologists performed the cell wash procedure for the second unrelated allogeneic hpc, cord blood unit in preparation for infusion into the designated recipient.After completing the centrifugation of the product, the technologists removed the centrifuge bucket from the centrifuge, and observed that an integrity failure of the cell wash/infusion set had occurred a second time.Visual examination of the cell wash/infusion bag for this incident revealed the majority of the seal at the bottom of the bag had failed.The product emptied from the bag but remained contained to the centrifuge bucket support insert for product recovery.An internal investigation was initiated to assess the findings of this incident.The current mfr's product insert for the cell wash/infusion set 791-03 was obtained from (b)(4) to verify the acceptable maximum recommended fill volumes for each bag as well as the recommended centrifuge speed.The product insert indicates a maximum recommended fill volume for each bag of 250ml and further indicates not to centrifuge at more than 1500g for 30 minutes.The product volume washed and centrifuge speed used for the cell wash procedure was far below the mfr's recommendations.Centrifugation and testing of mock cell wash/infusion sets filled to a volume similar to that of the pt product and centrifuged at 880g yielded similar results in which the seal at the base of the bag failed for sets tested.The physical integrity of 7 our of 8 mock cell wash/infusion sets tested and centrifuged at 400g remained in tact.A single integrity failure observed at 400g resulted in a small pin hole occurring at the bottom seal.

• Brand Name: PALL MEDICAL
• Type of Device: CELL WASH/INFUSION SET
• Manufacturer (Section D): PALL CORPORATION; 25 harbor park dr.; port washington NY 11050
• MDR Report Key: 5573349
• MDR Text Key: 42770205
• Report Number: MW5061646
• Device Sequence Number: 0
• 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,Followup
• Report Date: 04/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 791-03
• Device Lot Number: 1553126
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/15/2016
• 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: 6 MO
• Patient Weight: 8