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

Model Number 8110

Device Problem Pumping Problem (3016)

Patient Problems Bruise/Contusion (1754); Unspecified Infection (1930); Skin Inflammation (2443)

Event Date 01/20/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical product(s): bd saf-t-intima closed catheter system; syringe; td (b)(6) 2020.Although requested, device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.

Event Description

It was reported that the patient developed redness, hardness, and warmth at the site of rituximab administration that led to significant expansive bruising four to five days after the treatment.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, patient was given cephalexin (keflex) oral antibiotic.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 since the events, the clinicians reverted back to previous practice.

• Brand Name: ALARIS® SYRINGE PUMP MODULE
• Type of Device: SYRINGE INFUSION PUMP
• 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: mustafa omar ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 9999082
• MDR Text Key: 188935145
• Report Number: 2016493-2020-00615
• 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: 04/25/2020
• 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
• Treatment: SYR TUBING,8015, TD (B)(6) 2020
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR