MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1® DISPOSABLE NORMOTHERMIC IV ADMINISTRATION SET; DEVICE, WARMING. BLOOD AND PLASMA

Catalog Number DI-50

Device Problems Insufficient Flow or Under Infusion (2182); Infusion or Flow Problem (2964)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/07/2016

Event Type  Injury  

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.(b)(4).

Event Description

It was reported that during use on a patient, the device and related disposable tubing were only able to infuse approximately half of expected blood units required.A massive transfusion protocol was activated on a patient experiencing a massive hemorrhage.The staff attempted to use a 14 and 16 gauge cannula without success.A central line was also unsuccessful.Ultimately the hospital staff ended up squeezing the blood through to the patient manually.A total of 32 units of blood had been opened in the attempt to manually infuse blood into the patient.The procedure lasted 4 hours and 10 minutes.The patient was discharged to the intensive care unit (icu) following procedure and was in critical condition.The clinical nurse stated "that this event could be one of several factors leading to the patient's current condition, however, it is hard to conclude that the device was responsible." see mfr: 3012307300-2016-00223.

• Brand Name: LEVEL 1® DISPOSABLE NORMOTHERMIC IV ADMINISTRATION SET
• 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 MEDICAL OAKDALE; 3350 granada avenue north; suite 100; oakdale MN 55128
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6069364
• MDR Text Key: 58843920
• Report Number: 3012307300-2016-00224
• Device Sequence Number: 1
• Product Code: KZL
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: BK860023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DI-50
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Life Threatening; Other; Required Intervention