MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC., HOTLINE BLOOD AND FLUID WARMER; LGZ - WARMER, THERMAL, INFUSION FLUID

Catalog Number HL-90

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

(b)(4).

Manufacturer Narrative

Customer has not yet returned the device to the manufacturer for device evaluation.When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the evaluation.

• Brand Name: HOTLINE BLOOD AND FLUID WARMER
• Type of Device: LGZ - WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.,; rockland MA
• Manufacturer (Section G): SMITHS MEDICAL ASD,INC.,; 160 weymouth st.; rockland MA 02370
• Manufacturer Contact: michele seliga ; 1265 grey fox rd.; st. paul, MN 55112 ; 6516287604
• MDR Report Key: 4736771
• MDR Text Key: 5823756
• Report Number: 2183502-2015-00276
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• PMA/PMN Number: K911383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Type of Report: Initial

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: Health Professional
• Device Catalogue Number: HL-90
• Was Device Available for Evaluation?: No
• Device Age: 4 YR
• Initial Date Manufacturer Received: 04/03/2015
• Initial Date FDA Received: 04/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1