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

Model Number ZIT-500-10

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 03/04/2022

Event Type  malfunction  

Manufacturer Narrative

Reportable as this is attached to an arterial line and can impact patient therapy.

Event Description

The pressure is leaking in these disposable pressure infusors.

Event Description

The pressure is leaking in these disposable pressure infusors.

Manufacturer Narrative

Reportable as this is attached to an arterial line and can impact patient therapy.Capa-00442 ongoing for corrective actions related to pressure loss and gauge tube detachment.Customer notified of capa project.Ra: risk of pressure loss identified in rma-20012a # r5 with severity of 6 - major.

• Brand Name: SALTER LABS
• Type of Device: INFUSOR, INFUSEIT 500 ML W/STOPCOCK
• Manufacturer (Section D): SALTER LABS; 30 spur drive; el paso 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: 13870411
• MDR Text Key: 296777642
• Report Number: 3000219639-2022-00014
• Device Sequence Number: 1
• Product Code: KZD
• Combination Product (y/n): N
• Reporter Country Code: FI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZIT-500-10
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/04/2022
• Initial Date FDA Received: 03/23/2022
• Supplement Dates Manufacturer Received: 03/04/2022
• Supplement Dates FDA Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other