MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1 HOTLINE BLOOD AND FLUID WARMER; WARMER, THERMAL, INFUSION FLUID

Model Number HL-90

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2024

Event Type  malfunction  

Manufacturer Narrative

B3: date of event and d5: operator of device is unknown; no information has been provided to date.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 Description

It was reported that there was water leaking from the side.The event occurred before patient use.

Manufacturer Narrative

Investigation summary: the affected device was received for evaluation.Visual inspection confirmed that there was a crack in the drain part of the enclosure.Functional testing confirmed that water was leaking from the drain part of the tank, confirming the customer's indicated failure.The cause is a crack in the enclosure.Based on the cracks, it is assumed that the impact was applied to the drain section of the main unit.The most likely cause is that the unit has been subjected to shock.The enclosure, gasket, and ac power cord were replaced, and the device passed all functional and performance testing.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

• Brand Name: LEVEL 1 HOTLINE BLOOD AND FLUID WARMER
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18646587
• MDR Text Key: 334756472
• Report Number: 3012307300-2024-00552
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K911383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/26/2024

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
• Device Operator: Other
• Device Model Number: HL-90
• Device Catalogue Number: HL-90JP
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/22/2024
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/10/2024
• Initial Date FDA Received: 02/05/2024
• Supplement Dates Manufacturer Received: 02/27/2024
• Supplement Dates FDA Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1