MAUDE Adverse Event Report: SALTER LABS INFUSEIT; INFUSEIT 500 ML REUSABLE PRESSURE INFUSOR

Model Number	ZIT-520-5
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the sleeve came off when pressurized it by injecting saline solution between the airbag and the sleeve.We are using it according to the instructions, but since the sleeve continues to be damaged, i would like to know the correct usage method.
Additional Manufacturer Narrative
H6: 4756 (appropriate impact term/code not available): pressure infusor.The product involved in the report has not been returned.A review of the device history record is in-progress.All information reasonably known as of 24 oct 2024 has been included in the health authority report.Should additional information be obtained a follow-up health authority report will be provided.The information provided by sunmed holdings llc.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 sunmed holdings llc.Sunmed holdings llc.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 sunmed holdings complaint database and is 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 a sunmed holdings llc.Product is defective or causes serious injury.
Event or Problem Description
It was reported that the sleeve came off when pressurized it by injecting saline solution between the airbag and the sleeve.We are using it according to the instructions, but since the sleeve continues to be damaged, i would like to know the correct usage method.
Additional Manufacturer Narrative
H6: 4756 (appropriate impact term/code not available): pressure infusor.The product involved in the report has not been returned.A review of the device history record is in-progress.All information reasonably known as of 24 oct 2024 has been included in the 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 sunmed holdings complaint database and is 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 causes serious injury.The complaint reported an issue where "the sleeve came off when pressurized by injecting saline solution between the airbag and the sleeve." an investigation confirmed that no patients were affected; however, the issue did occur during patient use.The supplier's investigation verified that the sleeve separation led to splitting.The root cause was attributed to undefined specifications for peel strength and heat-sealing strength.The manufacturing site has implemented enhanced corrective actions.According to the supplier's findings, the root cause was the absence of defined specifications for peel strength and heat-sealing strength, resulting in these properties being weaker in the first lot: (22051413) compared to others.Per the risk assessment performed in the activity log, the risk determination (low) indicates that the complaint does not need to be submitted to the capa review board.There were 9 complaints reported for part number: zit-520 for "falling apart/adhesive failure." there were 30 complaints reported for part number: zit-520 during the same timeframe related to different failure mode.A resolution letter was sent to the customer.We will continue to monitor trends during our periodic complaint review meetings.

• Brand Name: INFUSEIT
• Common Device Name: INFUSEIT 500 ML 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: 20527384
• Report Number: 3000219639-2024-00101
• Device Sequence Number: 13054150
• Product Code: KZD
• UDI-Device Identifier: 10607411916912
• UDI-Public: (01)10607411916912(10)230200827
• 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: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2025

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-520-5
• Device Catalogue Number: ZIT-520-5
• Device Lot Number: 230200827
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2024
• Supplement Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown