MAUDE Adverse Event Report: SMITHS HEALTHCARE MFG LEVEL 1 ® DISPOSABLE NORMOTHERMIC IV ADMINISTRATION SETS; DEVICE, WARMING. BLOOD AND PLASMA

Catalog Number DI-50

Device Problem Insufficient Information (3190)

Patient Problem Pulmonary Embolism (1498)

Event Date 04/22/2016

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.

Event Description

User facility reported that the device was in use with patient (time in use not provided).According to reporter, air was seen in the line and patient sustained a lung embolism.Additional information has been requested regarding patient treatment.No permanent adverse effects have been reported.

Manufacturer Narrative

One used level 1 ® disposable normothermic iv administration set was returned for investigation.The sample was received inside a plastic bag and without its original packaging.Visual inspection was performed at distance of 12" to 24" and under normal conditions of illumination.Examination found no damage with the sample.During functional testing, the sample was connected to a level 1® h-1200 fast flow fluid warmer.After 5 minutes, which is the time required to empty a 1500ml fluid supply bag, the assembly showed no occlusions or air bubbles within the fluid path and the filter gas vent assembly was noted to be properly eliminating the bubbles from the system.The manufacturing facility performed a review of the manufacturing process.The review showed that assembly process was being performed as per procedures: this included review of basic assembly, pressure testing, and a review of the cap, vent with membrane that was being used during the manufacturing process.The manufacturing facility also performed an in-process visual inspection of (b)(4) products that were in the assembly area: the inspection showed no product damage or discrepancies that could result in air in the line.Investigation was unable to confirm the reported issue and found that the sample operated as intended.(b)(4).

• Brand Name: LEVEL 1 ® DISPOSABLE NORMOTHERMIC IV ADMINISTRATION SETS
• Type of Device: DEVICE, WARMING. BLOOD AND PLASMA
• Manufacturer (Section D): SMITHS HEALTHCARE MFG; s.a. de c.v. ave; calidad no. 4; tijuana, 22425 ; MX 22425
• Manufacturer (Section G): SMITHS HEALTHCARE MFG; s.a. de c.v. ave; calidad no. 4; tijuana, 22425 ; MX 22425
• Manufacturer Contact: lisa perz ; 1265 grey fox road; st paul, MN 55112 ; 7633833074
• MDR Report Key: 5812080
• MDR Text Key: 50099235
• Report Number: 2183502-2016-01499
• Device Sequence Number: 1
• Product Code: KZL
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: BK860023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2020
• Device Catalogue Number: DI-50
• Device Lot Number: 3151168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2016
• 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
• Patient Outcome(s): Required Intervention