MAUDE Adverse Event Report: SALTER LABS SALTER LABS; INFUSOR,REUSABLE,INFUSEIT 500 ML W/STOPCOCK

Model Number	ZIT-520-5
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pressure bag leaking pressure could delay or interrupt therapy.This is attached to an arterial line and can impact patient therapy.Based on the reported information the criteria for reporting an adverse event have been met.
Event or Problem Description
The gauge disconnected from the tubing.
Additional Manufacturer Narrative
The pressure bag leaking pressure could delay or interrupt therapy.This is attached to an arterial line and can impact patient therapy.Based on the reported information the criteria for reporting an adverse event have been met.Summary: capa-00463 initiated for this reported failure mode.Capa has been implemented and pre-dates manufacturing date of product associated with this complaint.Ra: pressure leaking caused by inadequate or defective materials including gauges is identified in the risk analysis at a 6 (major).
Event or Problem Description
The gauge disconnected from the tubing.

• Brand Name: SALTER LABS
• Common Device Name: INFUSOR,REUSABLE,INFUSEIT 500 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: 14717432
• Report Number: 3000219639-2022-00028
• Device Sequence Number: 2350846
• Product Code: KZD
• UDI-Device Identifier: 10607411916912
• UDI-Public: 10607411916912
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2022

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: 20210719
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2022
• Supplement Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 06/16/2022
• Supplement Report FDA Received Date: 06/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown