MAUDE Adverse Event Report: CAREFUSION ALARIS® SYRINGE MODULE; PUMP, INFUSION

Model Number 8110

Device Problem Pumping Problem (3016)

Patient Problems Unspecified Infection (1930); Skin Discoloration (2074)

Event Date 02/13/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: spm tubing; 8015; bd saf-t-intima closed catheter system; syringe; therapy date (b)(6) 2020.Although requested, the affected devices have not been received.A follow up report will be submitted with investigation results should the devices be received for evaluation.

Event Description

It was reported that the patient a large red area with black center and red rim spreading on the abdomen, which was the site of rituximab administration.The rituximab 1400mg was administered subcutaneously in the abdominal area using saf-t-intima iv catheter through syringe pump over 5 minutes.The pump was programmed used guardrails drug library.Due to the symptoms, the patient was admitted to the hospital for intravenous administration of antibiotics as well as infectious disease consult for possible cellulitis.The patient did not receive any additional rituximab, either intravenously or subcutaneously.Furthermore, it was mentioned that subcutaneous rituximab has been previously given through slow syringe administration.The facility recently changed their practice and began using syringe pumps.There were no reported incidents prior to use of pumps and after the event, the clinicians reverted to previous practice.

• Brand Name: ALARIS® SYRINGE MODULE
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: stephen bilello ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 9993469
• MDR Text Key: 192016735
• Report Number: 2016493-2020-00607
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K023264
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8110
• Device Catalogue Number: 8110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR