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

Model Number 2426-0007

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems High Blood Pressure/ Hypertension (1908); Hypoxia (1918); Tachycardia (2095)

Event Date 09/05/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant product(s): a 250ml baxter bag ndc 0338-0049-02, lot number y273193, exp dec 19 0.9%, sodium chloride.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 they were attempting to associate a levophed 16 mg/250 ml infusion with an alaris device and received a communication error #9007 message.The infusion had not yet been started because of the error, however the medication still infused.It was stated "bag not as full as should be for just attempting to start medication." the customer reported they use pump integration (presumed to mean interoperability).The patient had an elevated blood pressure, elevated heart rate, and some hypoxia which the rn suspected was caused by the bolus of medication.The patient's condition resolved to baseline vitals at approximately 1010, which was within 20 minutes of the first abnormal vital sign at 0954.A new data set had been released at the facility (b)(6) 2018, the day before the event.

Manufacturer Narrative

Correction: disregard the initial report as the disposable is no longer considered the suspect, please see 2016493-2018-00730 for mdr reporting.

Event Description

The customer reported they were attempting to associate a levophed 16 mg/250 ml infusion with an alaris device and received a communication error #9007 message.The infusion had not yet been started because of the error, however the medication still infused.It was stated "bag not as full as should be for just attempting to start medication." the customer reported they use pump integration (presumed to mean interoperability).The patient had an elevated blood pressure, elevated heart rate, and some hypoxia which the rn suspected was caused by the bolus of medication.The patient's condition resolved to baseline vitals at approximately 1010, which was within 20 minutes of the first abnormal vital sign at 0954.A new data set had been released at the facility (b)(6) 2018, the day before the event.

• 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
• MDR Report Key: 7920852
• MDR Text Key: 122147446
• Report Number: 9616066-2018-01846
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403227998
• UDI-Public: 10885403227998
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2426-0007
• Device Catalogue Number: 2426-0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8100,8015, THERAPY DATE (B)(6) 2018
• Patient Outcome(s): Other