MAUDE Adverse Event Report: SALTER LABS SALTER LABS; INFUSOR, INFUSEIT 3000 ML W/STOPCOCK

Model Number	ZIT-3000-10
Medical Device Problem Codes	Burst Container or Vessel (1074); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sudden burst of the pressure infusion bag may delay treatment, but the clinician would be able to mitigate this by manually squeezing the fluid bag to ensure treatment is being administered.There was no report that a patient was impacted by the burst of the bag.
Event or Problem Description
During use, inflated to 300mmhg, it suddenly bursted/ exploded.
Event or Problem Description
During use, inflated to 300mmhg, it suddenly bursted/ exploded.
Additional Manufacturer Narrative
The sudden burst of the pressure infusion bag may delay treatment, but the clinician would be able to mitigate this by manually squeezing the fluid bag to ensure treatment is being administered.There was no report that a patient was impacted by the burst of the bag.The complaint confirmed the defect of adhesive failure.It was identified that the adhesive between the plastic sleeve and air bladder failed resulting in the separation observed by the customer.The most probable root cause is inadequate adhesion between the two components during the manufacturing process.

• Brand Name: SALTER LABS
• Common Device Name: INFUSOR, INFUSEIT 3000 ML W/STOPCOCK
• 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: 18460348
• Report Number: 3000219639-2023-00041
• Device Sequence Number: 3115338
• Product Code: KZD
• UDI-Device Identifier: 00607411911910
• UDI-Public: 00607411911910
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2024

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: ZIT-3000-10
• Device Catalogue Number: ZIT-3000-10
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2023
• Supplement Date Received by Manufacturer: 12/08/2023
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 03/20/2024
• Was Device Evaluated by Manufacturer? (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