MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1® FAST FLOW FLUID WARMER DISPOSABLE ADMINISTRATION SETS; DEVICE, WARMING. BLOOD AND PLASMA

Catalog Number D-300

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/17/2016

Event Type  malfunction  

Manufacturer Narrative

Customer has not returned the device to the manufacturer for device evaluation.If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.(b)(4).

Event Description

It was reported that a level 1 fast flow fluid warmer disposable administration set was used during resuscitation when the blood product was severely delayed during a rapid blood transfusion.It was unknown whether a central line or a peripheral intravascular catheter was used.No medical intervention was required and no patient injury was reported.

• Brand Name: LEVEL 1® FAST FLOW FLUID WARMER DISPOSABLE ADMINISTRATION SETS
• Type of Device: DEVICE, WARMING. BLOOD AND PLASMA
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS HEALTHCARE MFG; s.a. de c.v. ave calidad no. 4; parque industrial internaciona; tijuana, b.c. 22425 ; MX 22425
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6077056
• MDR Text Key: 59134141
• Report Number: 3012307300-2016-00241
• Device Sequence Number: 1
• Product Code: KZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK860023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2020
• Device Catalogue Number: D-300
• Device Lot Number: 3151180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1