MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1 NORMOTHERMIC IV FLUID ADMIN SET; DEVICE, WARMING. BLOOD AND PLASMA: KZL

Model Number	D-300
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354); Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/10/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that upon priming the tubing on a smiths medical level 1 normothermic iv fluid admin set, it was leaking at one of the priming spike.No patient involvement.
Additional Manufacturer Narrative
Investigation results completed on fluid warming|level 1 trauma fast flow disposables.The disposable in incident arrived and was visually inspected, finding the solvent bond between the spike and drip chamber.When testing was done the complaint was verified at the specific area visualized indicating the solvent bond adhesive root cause.No discrepancies were found in the quality review of the device.Corrective action was taken :co-10076908 was released on 17-sep-2019 to update the manufacturing process due the implementation of the new medical solvent dispenser, the operations of the drip chamber assembly were updated for refer the new dispenser.
Event or Problem Description
Investigation results completed on fluid warming|level 1 trauma fast flow disposables in h 10.

• Brand Name: LEVEL 1 NORMOTHERMIC IV FLUID ADMIN SET
• Common Device Name: DEVICE, WARMING. BLOOD AND PLASMA: KZL
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 9685106
• Report Number: 3012307300-2020-00932
• Device Sequence Number: 11676178
• Product Code: KZL
• UDI-Device Identifier: 20695085430008
• UDI-Public: 20695085430008
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: BK860023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2020

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
• Operator of Device: Health Professional
• Device Model Number: D-300
• Device Catalogue Number: D-300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2020
• Supplement Date Received by Manufacturer: 01/10/2020
• Initial Report FDA Received Date: 02/09/2020
• Supplement Report FDA Received Date: 03/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1