MAUDE Adverse Event Report: CAREFUSION ALARIS® PUMP MODULE ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 2420-0007

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem Hyperthermia (1909)

Event Date 03/23/2016

Event Type  Injury  

Manufacturer Narrative

The affected product has been received and the evaluation is pending.A follow up report will be submitted once the evaluation is completed.

Event Description

The customer reported that an icu patient was receiving a secondary iv of vancomycin; reportedly, at 10:30am no brown substance was observed, however when the patient arrived in pacu at 11:55 am, the nurse noticed a brown substance in the primary line and drip chamber.The patient experienced fever and elevated white blood count.Preliminary reports for blood, urine and infusion set cultures showed no growth.

Manufacturer Narrative

Concomitant products: green curos cap; 500ml infusion bag containing approximately 100ml of 0.9% nacl (baxter lot y005629, exp.03/17, ndc (b)(4)); 500ml infusion bag (baxter lot y005504, exp.03/17, ndc (b)(4)) containing approximately 50ml of vancomycin/nacl injection, 1.75g in ns 500ml; therapy date (b)(6) 2016.The customer¿s report of a brown substance in the tubing was confirmed.Visual inspection showed a brown flake-like substance floating within the tubing of the primary set, observed at around 31 inches from the distal end of the set and scattered in the iv liquid down to the distal end.The substance appeared somewhat water soluble because the liquid surrounding the larger concentrations of the substance in the tubing had a slight yellow/brown tinge.Ftir testing showed that the best match for this contaminant is blood.Functional testing of the primary and secondary sets showed no issues.The root cause of the contamination could not be identified.

• Brand Name: ALARIS® PUMP MODULE ADMINISTRATION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 5595118
• MDR Text Key: 43232620
• Report Number: 9616066-2016-00535
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2019
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other