MAUDE Adverse Event Report: S.A.L.F. LABORATORIO FRAMACOLOGICO SERVATOR H; SET, PERFUSION, KIDNEY, DISPOSABLE

Device Problem Product Quality Problem (1506)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

Product claims to have shell life of 18 months.Fda approval for 12 months.Product is very yellow in color.Temperature guidelines are not the same as predicate.Fda safety report id# (b)(4).

• Brand Name: SERVATOR H
• Type of Device: SET, PERFUSION, KIDNEY, DISPOSABLE
• Manufacturer (Section D): S.A.L.F. LABORATORIO FRAMACOLOGICO
• MDR Report Key: 8604843
• MDR Text Key: 145017886
• Report Number: MW5086577
• Device Sequence Number: 1
• Product Code: KDL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/10/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention