MAUDE Adverse Event Report: SMITH¿S MEDICAL ASD, INC. LEVEL 1 FAST FLOW CONSIGNED IRRIGATION FLUID WARMER; WARMER, THERMAL, INFUSION FLUID

Model Number	H-1129
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.No information has been provided to date.Reason device not evaluated by mfg: other; device was 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.
Event or Problem Description
It was reported that the device pressure was not matching the gauge and it was going high into the red; the electrical safety was not passing.The issue was found during testing.There was no patient involvement, and no harm/adverse event was reported.
Additional Manufacturer Narrative
D9.Date returned to mfg: 02-jul-2024.H6.Investigation codes: updated.Investigation summary: the affected device was returned for evaluation.Visual inspection was performed.The device was received in with the hi-2 pressure chamber bracket, power pole/power base and two h-2 pressure chambers.The h-2 pressure chambers are the incorrect model to be paired with the h-1129 irrigation unit, hi-2 pressure chambers are the only ones to be used.The back panel ground wire has been cut and is pinched in between the enclosure and back panel; it is also sticking out from either side of the device.The screws for the back panel have been overtightened to where most of them become stripped while trying to remove them.The customer broke multiple inserts (where screws for back panel are secured, more than likely broke free from overtightening) on the enclosure and also one on the back panel where the hi-2 bracket screws are inserted.There is visual calcium/mineral build up in the return tube and reservoir (probably entire water circuit) from the wrong solution being used, the device should only be filled with distilled water or a 0.3% hydrogen peroxide/distilled water mix and changed as advised in the tech/user manual.The hi-2 bracket has a drilled-out screw hole, customer damage, and has to be scrapped.Heater's #1 and #2 both have a rip in the insulation.The gauge box pressure readings are out of tolerance, the air pressure readings are too low.H-2 pressure readings were in the red because they are the wrong model pressure chambers to be paired with an h-1129 irrigation model.The customer's complaint was confirmed.The high-pressure readings are due to user error, due to the fact that the wrong model (h-2) pressure chambers that are operated at a lower psi (5.6psi) were used instead of the hi-2 pressure chambers that are operated at (11.0psi).Could not perform electrical testing due to customer damage to the back panel ground wire, which was broken.No actions taken due to user error, pressure chambers work as intended when operated at the correct air pressure, 5.6psi.Due to extensive repairs needed, the trauma tower has been deemed beyond economical repair.

• Brand Name: LEVEL 1 FAST FLOW CONSIGNED IRRIGATION FLUID WARMER
• Common Device Name: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): SMITH¿S MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19566817
• Report Number: 3012307300-2024-05180
• Device Sequence Number: 15197144
• Product Code: LGZ
• UDI-Device Identifier: 50695085812904
• UDI-Public: (01)50695085812904(11)100430
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K072080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2024

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 Model Number: H-1129
• Device Catalogue Number: CON-H-1129
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2024
• Supplement Date Received by Manufacturer: 07/15/2024
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2010
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown