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

Catalog Number R4R9953

Device Problems Leak/Splash (1354); Material Rupture (1546)

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

Event Date 10/04/2014

Event Type  malfunction  

Event Description

A customer informed us that he observed ¿exploding closure caps¿ of (old) cryocyte bags, code r4r9953, and that he is therefore, not able to retrieve the frozen product under sterile conditions.No batch numbers, quantities, or any other information communicated so far.Customer first contacted miltenyi (former distributor of cryocyte bags), but they told that they are not responsible.

Manufacturer Narrative

Complaint no: (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 adverse event if it were to reoccur.Please know this product is end of life.A follow-up report will be submitted upon completion of the investigation.

Manufacturer Narrative

(b)(4).Baxter mountain home completed the investigation.As neither sample nor batch number are available, a sample evaluation and batch review could not be performed.Units were 100% inspected pre-sterilization by production during the manufacturing process.No batch number received therefore, no results of inspections could be reviewed.This product is in the end of life proceedings and is no longer manufactured.No trend is identified.---------- the complainant reported a cryocyte bag rupture that is consistent with breakage investigated in a corrective and preventive action record (capa# (b)(4)).(b)(4) was initiated to address this issue.As a result of multiple analyses, the two contributing root causes were identified as: 1) nitrogen ingress through the ports resulting in breakage when nitrogen gas expands during thawing leading to a brittle fracture, and 2) customer usage variability.The following process improvements were initiated: 1) minimizing manufacturing variability through "mistake proofing", and 2) minimizing customer usage variability by clarifying the "instructions for use" through label copy improvements.However, it must be noted that routine complaint monitoring has revealed a decrease in the field complaint rate before any actions were implemented.(b)(4) was closed on january 28, 2009.Complaint monitoring has been conducted to identify complaints for lots produced post corrective action.This product is end of life.This case will be kept on file for trending purposes.

• 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: 4171346
• MDR Text Key: 15361732
• Report Number: 1416980-2014-35840
• Device Sequence Number: 1
• Product Code: KSR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: BK950049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: R4R9953
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/31/2014
• 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