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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION ALARIS SYRINGE PUMP MODULE; PUMP, INFUSION
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CAREFUSION ALARIS SYRINGE PUMP MODULE; PUMP, INFUSION Back to Search Results
Model Number 8110
Device Problems Infusion or Flow Problem (2964); Pumping Problem (3016)
Patient Problems Cellulitis (1768); Erythema (1840); Pain (1994)
Event Date 03/09/2020
Event Type  Injury  
Manufacturer Narrative
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 at the site of rituximab administration that required admission to the hospital for possible cellulitis.The medication was administered subcutaneously using saf-t-intima iv catheter through syringe pump.It was noted that the patient was well.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 back to previous practice.
 
Manufacturer Narrative
Revision of b3 and b5 - additional information a2, a3, b7.Although requested, information on a1, a4, race and ethnicity were not provided.
 
Event Description
It was reported that the patient developed large area of redness, painful, and warm to touch at the site of rituximab administration that led to significant expansive bruising twenty four hours 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.
 
Manufacturer Narrative
Correction: revised b5.Additional information added to: b3,d11.
 
Event Description
It was reported that the patient developed redness at the site of rituximab administration that required admission to the hospital for possible cellulitis.The medication was administered subcutaneously using saf-t-intima iv catheter through syringe pump.It was noted that the patient was well.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.It was then reported that three separate incidents occurred: (b)(6), (b)(6), and (b)(6).Other than the reported possible cellulitis event, the other were two patients developing redness at site of administration with significant expansive bruising.Although requested, additional information was not provided, and it was not specified what event occurred on the date provided.
 
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Brand Name
ALARIS SYRINGE PUMP MODULE
Type of Device
PUMP, INFUSION
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key9882640
MDR Text Key188206939
Report Number2016493-2020-00414
Device Sequence Number1
Product Code FRN
Combination Product (y/n)N
PMA/PMN Number
K023264
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 03/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/26/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8110
Device Catalogue Number8110
Was Device Available for Evaluation? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
SAF-T-INTIMA CLOSED CATHETER SYSTEMSYRINGE.; SYR TUBE,8015, THERAPY DATE (B)(6) 2020.
Patient Outcome(s) Other;
Patient Age71 YR
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