MAUDE Adverse Event Report: B. BRAUN OF DOMINICAN REPUBLIC Y-TYPE BLOOD SETS

Catalog Number 490321

Device Problem Insufficient Information (3190)

Patient Problems Bradycardia (1751); Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); Urticaria (2278); Complaint, Ill-Defined (2331)

Event Type  Injury  

Event Description

As reported by the user facility: event #3: reports five patients over the last 2 months have experienced allergic type reactions such as red face and shortness of breath.One pt experienced hives.With another pt, the baby's heart rate decreased and an emergency c-sections were performed.The reactions occurred approximately 2-3 minutes after commencement of iv therapy with plasmalyte (manufactured by baxter).This has occurred in the l and d department in otherwise healthy women with no known allergies.No other medication was administered to the pt at this time.

Manufacturer Narrative

This report has been identified as b braun medical inc internal report # (b)(4).One (1) unused, unopened blood set, identifying the reported lot number 0061389717, was received for evaluation.A thorough review of the sterilization record was conducted for the reported lot number.This included a review of the biological indicator (bi) and bacteria endotoxin (lal) test results.All results were found to be acceptable and within specification.No abnormalities were noted that could have potentially contributed to the reported events.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or nonconformances of this nature.A historical review of the customer complaint database performed for all lot number contained within the involved sterilization load revealed no other incidents of this nature.There is no current info available to suggest that the b braun blood set caused or contributed to the reported event.If additional pertinent info that impacts the decision and result of the investigation becomes available, a follow-up report will be filed.

• Brand Name: Y-TYPE BLOOD SETS
• Type of Device: Y-TYPE BLOOD SETS
• Manufacturer (Section D): B. BRAUN OF DOMINICAN REPUBLIC; santo domingo ; DR
• Manufacturer Contact: eric roden ; las americas industrial park; km22 autopista las americas; santo domingo ; DR ; 8095491000
• MDR Report Key: 4561965
• MDR Text Key: 16541535
• Report Number: 9614279-2015-00008
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K8402121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 490321
• Device Lot Number: 0061389717
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/12/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2014
• 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
• Treatment: PLASMALYTE IV THERAPY
• Patient Outcome(s): Other