MAUDE Adverse Event Report: BAXTER HEALTHCARE - MOUNTAIN HOME CRYOCYTE PACK; CONTAINER, EMPTY, FOR COLLECTION & PROCESSING OF BLOOD & BLOOD COMPONENTS

Catalog Number R4R9953

Device Problems Crack (1135); Device Disinfection Or Sterilization Issue (2909)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2014

Event Type  malfunction  

Event Description

It was reported by a customer she had an issue with one cryocyte freezing container.The customer stated that cord blood was frozen in the container on (b)(6) 2009 and the bag cracked upon thawing prior to patient infusion.This lead to a loss of product and potentially compromised the sterility.There was no patient injury or medical intervention reported with this event.  no additional information is available at this time.

Manufacturer Narrative

(b)(4).Baxter medical assessment: this is a cryocyte bag breakage that was discovered.There have been no reported negative clinical consequences for the patient.As in all cases of cryocyte bag breakages during storage there is the potential of loss of engraftment or delay in engraftment with the loss of product.This puts the patient at greater risk.As such, a breakage could potentially cause or contribute to an event if it were to reoccur.Please know this product is end of life.A follow-up report will be submitted upon receipt and evaluation of additional information.

• Brand Name: CRYOCYTE PACK
• Type of Device: CONTAINER, EMPTY, FOR COLLECTION & PROCESSING OF BLOOD & BLOOD COMPONENTS
• Manufacturer (Section D): BAXTER HEALTHCARE - MOUNTAIN HOME; 1900 n highway 201; mountain home AR 72653
• Manufacturer (Section G): BAXTER HEALTHCARE - MOUNTAIN HOME; 1900 n highway 201; mountain home AR 72653
• Manufacturer Contact: kimberly crane ; one baxter way; westlake village, CA 91362 ; 8053723182
• MDR Report Key: 3593864
• MDR Text Key: 16013034
• Report Number: 1416980-2014-02653
• Device Sequence Number: 1
• Product Code: KSR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK950049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2013
• Device Catalogue Number: R4R9953
• Device Lot Number: H08E08079
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/16/2014
• Initial Date FDA Received: 01/27/2014
• Date Device Manufactured: 05/09/2008
• 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