MAUDE Adverse Event Report: SALTER LABS INFUSEIT; INFUSELT 1000ML REUSABLE PRESSURE INFUSOR

Model Number	ZIT-1020
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All information reasonably known as of (b)(6) 2025 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by airlife.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to airlife.Airlife.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the airlife complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an airlife product is defective or caused serious injury.
Event or Problem Description
The pressure gauge and connection tube came off.Even after reconnecting, it comes off again immediately.
Event or Problem Description
The pressure gauge and connection tube came off.Even after reconnecting, it comes off again immediately.
Additional Manufacturer Narrative
All information reasonably known as of 17 april 2025 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by airlife.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to airlife.Airlife.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the airlife complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an airlife product is defective or caused serious injury.The complaint failure mode most closely aligns with risk id r7 with a potential cause of hazard being "inadequate or defective materials used in assemblies (i.E., bladder, sleeve, piston gauge) causing mechanical integrity loss".There have been a total of 5 complaints within a two-year timeframe (18mar2023-18mar2025) for part zit-1020-5.(see complaint history activity) during this timeframe, (b)(4) units were sold for part zit-1020-5, resulting in a field occurrence rate of (b)(4) remote (2).The product is performing well within the anticipated occurrence rate of remote (2) determined in the (b)(4).The severity for the failure mode is serious (3) and the overall patient/caregiver risk is determined to be low (10).Per the risk assessment performed in the activity log, the risk level is medium and the escalation qualifier determined by (b)(4), the complaint needs to be submitted to the capa review board.The complaint has been entered into (b)(4).

• Brand Name: INFUSEIT
• Common Device Name: INFUSELT 1000ML REUSABLE PRESSURE INFUSOR
• Manufacturer (Section D): SALTER LABS; 30 spur drive; el paso TX 79906
• Manufacturer (Section G): SALTER LABS; 30 spur drive; el paso TX 79906
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 21861973
• Report Number: 3000219639-2025-00040
• Device Sequence Number: 18084539
• Product Code: KZD
• UDI-Device Identifier: 00607411913396
• UDI-Public: (01)00607411913396(10)230100304
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2025

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 Model Number: ZIT-1020
• Device Catalogue Number: ZIT-1020
• Device Lot Number: 230100304
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2025
• Supplement Date Received by Manufacturer: 03/18/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown