MAUDE Adverse Event Report: SMITHS MEDICAL ASD LEVEL 1 TRAUMA FAST FLOW DISPOSABLES; DEVICE, WARMING, BLOOD AND PLASMA

Model Number	D-60HL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product sample was received and is awaiting evaluation and 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 the caregiver attempted to load and utilize tubing for the device.Shortly after setup and blood connected, the caregiver noticed that the tubing has snapped just above the filter.This incident delayed care due to the fact that additional tubing was needed and set up again.Eventually patient received transfusion.There was no patient harm reported, although the significant delay in transfusion could have potentially caused issues.Patient required additional crystalloid before blood could be administered.Patient was stabilized.
Additional Manufacturer Narrative
H10 device evaluation: part of a unit of p/n d-60hl was received without its original packaging, in unused condition, and decontaminated.The returned units were visually inspected, and it was determined what was received was the fluid supply assembly.It was observed that the connection between the drip chamber and the 3-y connector was broken.The failure mode reported was confirmed.Manufacturing processes were reviewed.It was determined that the root cause of this reported issue cannot be related to the manufacturing process.A review of the device history record (dhr) shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of products.Production personnel were trained on (b)(6) 2020 in the manufacturing procedure to reinforce the correct assembly.Action taken was after the lot reported manufacture date.

• Brand Name: LEVEL 1 TRAUMA FAST FLOW DISPOSABLES
• Common Device Name: DEVICE, WARMING, BLOOD AND PLASMA
• Manufacturer (Section D): SMITHS MEDICAL ASD; 6000 nathan ln n; plymouth MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD; 6000 nathan ln n; plymouth MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan ln n; plymouth, MN 55442
• MDR Report Key: 16108927
• Report Number: 3012307300-2023-00142
• Device Sequence Number: 15341597
• Product Code: KZL
• UDI-Device Identifier: 20695085406003
• UDI-Public: 20695085406003
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• 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: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2023

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: 06/06/2023
• Device Model Number: D-60HL
• Device Catalogue Number: D-60HL
• Device Lot Number: 3830285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2022
• Supplement Date Received by Manufacturer: 02/17/2023
• Initial Report FDA Received Date: 01/05/2023
• Supplement Report FDA Received Date: 03/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2019
• 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