MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. LEVEL 1 DISPOSABLE NORMOTHERMIC IV ADMIN SETS; DEVICE, WARMING, BLOOD AND PLASMA

Catalog Number	DI-60HL
Medical Device Problem Codes	Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was leakage found on the tubing system at the beginning of use (less than 3 minutes).Then the tube detached from the outer white tube.This problem was resolved by replacing with a new set.There was patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
H3: device not returned to manufacturer.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
D9: 26-nov-2024.H3: one used device was received for evaluation.As received, a separation was observed between the infuscate outlet tubing at the bottom of the heat exchanger.Little to no solvent was observed at the bonding sites.The complaint of leakage can be confirmed due to the separation observed.The probable cause is due to insufficient solvent coverage error during assembly in tijuana.The lot history was reviewed, no relevant nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: LEVEL 1 DISPOSABLE NORMOTHERMIC IV ADMIN SETS
• Common Device Name: DEVICE, WARMING, BLOOD AND PLASMA
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20878893
• Report Number: 9617604-2024-00926
• Device Sequence Number: 18096142
• Product Code: KZL
• UDI-Device Identifier: 20695085406010
• UDI-Public: (01)20695085406010(17)250628(10)4114262
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: BK860023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2025

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 Expiration Date: 06/28/2025
• Device Catalogue Number: DI-60HL
• Device Lot Number: 4114262
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2024
• Supplement Date Received by Manufacturer: 09/23/2025
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown