MAUDE Adverse Event Report: HOSPIRA LIFE SHIELD Y-TYPE BLOOD SET

Catalog Number CA-0717

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Low Blood Pressure/ Hypotension (1914); Reaction (2414)

Event Date 12/28/2015

Event Type  Injury  

Event Description

The pt received a transfusion of leukoreduced prbc's and became hypotensive when the transfusion began twice in one shift.Baseline arterial pressures were 90/40's and dropped to 60/20's within 10 mins of administration.The blood bank evaluation the specimen and it was not a transfusion reaction.The pt has since received two units of washed rbc's therefore removing the need for the filter and this reaction has not occurred.

• Brand Name: LIFE SHIELD Y-TYPE BLOOD SET
• Type of Device: Y-TYPE BLOOD SET
• Manufacturer (Section D): HOSPIRA; lake forest IL 60045
• MDR Report Key: 5341318
• MDR Text Key: 35030058
• Report Number: MW5058859
• Device Sequence Number: 1
• Product Code: BRZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CA-0717
• Device Lot Number: 1278-65
• Other Device ID Number: CA-0717
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/29/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Weight: 71