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

Model Number	DI-60HL
Medical Device Problem Codes	Break (1069); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that after priming, the first rbc (blood product) was administered under pressure, and while connecting the second rbc to the spike of the circuit, the operators hand slipped and separated the spike needle while it was still connected to the rbc.It is thought that the weight of one rbc was applied to the upper tip of the drip chamber, causing it to break and break off.There was patient involvement and no patient harm/adverse event reported.
Additional Manufacturer Narrative
H3 and h6 - updated.One device was received for investigation.The device was visually inspected and functionally tested.The reported problem was confirmed.The sample shows signs of manipulation; therefore, it cannot be confirmed that the failure mode reported in the complaint "separation" was generated during the manufacturing process.The root cause could not be determined.A review of the device history records could not be completed as no lot number was provided by the customer.

• 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: 18987896
• Report Number: 9617604-2024-00261
• Device Sequence Number: 11477754
• Product Code: KZL
• UDI-Device Identifier: 20695085406010
• UDI-Public: (01)20695085406010(17)260608(10)4293626
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: BK860023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2024

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: 06/08/2026
• Device Model Number: DI-60HL
• Device Catalogue Number: DI-60HL
• Device Lot Number: 4293626
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/11/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2024
• Supplement Date Received by Manufacturer: 04/03/2024
• Initial Report FDA Received Date: 03/27/2024
• Supplement Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2022
• 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