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

Model Number 2420-0007

Device Problems Excess Flow or Over-Infusion (1311); Infusion or Flow Problem (2964)

Patient Problems Bradycardia (1751); Cardiac Arrest (1762); Loss of consciousness (2418); Loss Of Pulse (2562)

Event Date 10/13/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 150ml braun bag ndc, 0264-1510-32, exp 04/19, 5% dextrose injection usp.The tubing set has been received and the evaluation is pending.A follow up report will be submitted with investigation results once the evaluation has been completed.

Event Description

The customer reported that an infusion of diltiazem 125mg/125 ml d5w was started at a rate of 10ml/hour with a vtbi of 120ml to slow the patient's heart rate.The patient experienced a change in heart rate and when the nurse entered the patient's room to titrate the drip rate down to 2.5ml/hr she noticed that the bag was empty.The nurse stopped the infusion and called the rapid response team.The patient was transferred to the icu for closer monitoring, continued to have severe bradycardia, and experienced asystole.Physician-ordered medications and fluids were required and the patient recovered.Pharmacy downloaded the event log from the suspect device; it was reviewed by the facility, reportedly verified what the nurse stated was programmed, and indicated that a total of 7ml had infused.Biomed then tested the pump with the same lot number of solution and tubing and found that the system functioned appropriately.The customer reported that a medwatch report was filed with the fda; however, did not provide a copy.There was no report of lasting harm caused to the patient.

Manufacturer Narrative

The suspect set is now a device and requires a new manufacturer report number.Please reference manufacturer report number (b)(4) for mdr reporting.

Event Description

The customer reported that an infusion of diltiazem 125mg/d5w 125ml was started at a rate of 10ml/hour with a vtbi of 120ml to slow the patient's heart rate.The patient experienced a change in heart rate and when the nurse entered the patient's room to titrate the drip rate down to 2.5ml/hr she noticed that the bag was empty.The nurse stopped the infusion and called the rapid response team.The patient was transferred to the icu for closer monitoring, in which the patient developed severe bradycardia, and then sinus arrest and was briefly pulseless and unresponsive.The physician ordered epinephrine, iv calcium and iv fluids to counteract the event.The patient responded well to the medications and remained stable and was transferred to an intermediate care unit the following day.Pharmacy downloaded the event log from the suspect device; it was reviewed by nursing, patient safety and biomed, to find that there was no user error noted.The investigation verified what the nurse stated was programmed, and indicated that a total of 7ml had infused.Biomed then tested the pump with the same lot number of solution and tubing and found that the system functioned appropriately and were unable to replicate the event.The customer reported that a medwatch report was filed with the fda however did not provide a copy.There was no report of lasting harm caused to the patient.Received a copy of the customer's medwatch report from the fda which states, "rn initiated diltiazem (cardizem) at 10mg/hr (10ml/hr) 40 mins after the 125ml bag was started, the pt developed bradycardia (^ 50) and rn noted.Almost the entire bag had infused.Rapid response team was called and arrived, provided iv fluid and iv calcium.(of course, medication infusion was stopped).Pt was asymptomatic at first, was transferred to icu.Shortly after arrival, he developed profound bradycardia, then sinus arrest.He was briefly pulseless and unresponsive.He responded to iv epinephrine, iv calcium and fluids.Following this, he remained stable and was transferred to intermediate care the following day.Review of programming history revealed that programming of medication concentration, rate etc was correct.Nursing, pt safety, and biomed engineers all reviewed event, found no user error, could not replicate the error.Bd alaris pump infusion set lot #(10) 18083068 sent to (b)(6); also carefusion alaris pump (channel) model 8100, sn (b)(4), ref#(b)(4) , carefusion (b)(4).Date of use: (b)(6) 2018; diagnosis or reason for use: infusion of cardizem diltiazem, atrial flutter.".

• 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: 8056516
• MDR Text Key: 126711236
• Report Number: 9616066-2018-02144
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203021012
• UDI-Public: 7613203021012
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/12/2021
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Device Lot Number: 18083068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8100, 8015, TD (B)(6) 2018; 8100, 8015, TD (B)(6) 2018
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR