MAUDE Adverse Event Report: TERUMO BCT HARVEST TERUMO; BONE MARROW ASPIRATE CONCENTRATE, BMAC, PROCEDURE PACK

Catalog Number BMAC26001

Device Problem Shelf Life Exceeded (1567)

Patient Problem No Information (3190)

Event Date 02/17/2015

Event Type  malfunction  

Event Description

The customer reported their facility accidently used a disposable kit that had expired on 01/31/2015.The representative from (b)(6) medical had left kits that expired 01/31/2015 on the shelf.The hospital staff did not notice the kit was expired until after they completed a procedure.The customer declined to provide procedure details and patient's information.The disposable kit is not available for return and investigation.

Manufacturer Narrative

Investigation: terumo bct consulted with a cell harvest product expert.The cell harvest product expert stated that the kit packaging had not been compromised during storage and if there had been an issue with the anticoagulant (ac), it would likely ended up with clotting problems and would not have made a usable product.Investigation is in-process.A follow-up report will be provided.

Manufacturer Narrative

Investigation: the kit was unavailable for return for evaluation or to confirm the complaint.All released product passed quality labs and sterilization requirements.Root cause: the disposable set was unavailable for return and root cause investigation.It is possible that the outer kit packaging was discarded, prior to use, which contained the correct kit expiry information, based on the shortest component expiration date.

Event Description

The customer indicated there was no patient reaction regarding the use of the expired kit.

• Brand Name: HARVEST TERUMO
• Type of Device: BONE MARROW ASPIRATE CONCENTRATE, BMAC, PROCEDURE PACK
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: robbin crafe ; 10811 w. collins ave; lakewood, CO 80215 ; 3032392282
• MDR Report Key: 4600606
• MDR Text Key: 16177446
• Report Number: 1722028-2015-00092
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103340
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2015
• Device Catalogue Number: BMAC26001
• Device Lot Number: 3002-0063
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other