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

Model Number 2420-0007

Device Problem Reflux within Device (1522)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/11/2019

Event Type  malfunction  

Manufacturer Narrative

No product will be returned per customer.The customer complaint could not be confirmed because the product was not sequestered for failure investigation.The root cause of this failure was not identified.Although requested, patient demographics not provided.

Event Description

The customer reported that a secondary infusion of 20 meq of kcl infused into the 500ml primary flush bag instead of the patient.The device did not alarm.

Event Description

The customer reported that a secondary infusion of 20 meq/100ml of kcl infused into the 500ml primary flush bag instead of the patient.After 30 minutes, the device alarmed for low battery and the clinician plugged the device into an electrical outlet.During an iv check, the clinician noticed the kcl bag was empty.The clinician reported they were able to see iv fluid flow back and forth between the primary and secondary infusion bags.There was no patient harm.Received a copy of the customer's medwatch report from the fda which states, "k+ infusion hung by iv piggyback, with ns in primary line.K+appeared to infuse faster than normal despite being on iv pump.After the set was disconnected from the pt and pump, it was noted that the iv piggyback fluid was flowing directly into the primary bag.Vendor notified.Apparently there is a known problem with sealant on the backcheck valves of primary tubing sets.".

Event Description

The customer reported that a secondary infusion of 20 meq/100ml of kcl infused into the 500ml primary flush bag instead of the patient.After 30 minutes, the device alarmed for low battery and the clinician plugged the device into an electrical outlet.During an iv check, the clinician noticed the kcl bag was empty.The clinician reported they were able to see iv fluid flow back and forth between the primary and secondary infusion bags.There was no patient harm.Received a copy of the customer's medwatch report from the fda which states, "k+ infusion hung by iv piggyback, with ns in primary line.K+appeared to infuse faster than normal despite being on iv pump.After the set was disconnected from the pt and pump, it was noted that the iv piggyback fluid was flowing directly into the primary bag.Vendor notified.Apparently there is a known problem with sealant on the backcheck valves of primary tubing sets.".

Manufacturer Narrative

The customer¿s secondary backflow from secondary to primary was confirmed.No anomalies were observed on the received sets during visual inspection.The check valve was also visually inspected under microscope; the check valve was noted to be assembled in the set correctly, and the silicone membrane was centered.Functional testing was performed by setting up a primary and secondary infusion set in the typical configuration.When the secondary roller clamp was opened, fluid and air bubbles were noted to be traveling past the check valve into the primary bag from the secondary iv set.The check valve was also sent to the supplier for additional analysis.Disassembly of the check valve resulted in a presence of the membrane diaphragm pinch.No particles were found on the membrane diaphragm or within the component.The root cause of the customer's report was not identified.

Manufacturer Narrative

Correction: event description and concomitant medical products.Concomitant medical products: 500ml baxter bag ndc 0338-0049-03 lot y280396 exp jan20 0.9% sodium chloride injection; 100ml hospira bag ndc 0409-7075-26 lot 88-121-jt exp 1oct2019 potassium chloride.

Event Description

The customer reported that a secondary infusion of 20 meq/100ml of kcl infused into the 500ml primary flush bag instead of the patient.After 30 minutes, the device alarmed for low battery and the clinician plugged the device into an electrical outlet.During an iv check, the clinician noticed the kcl bag was empty.The clinician reported they were able to see iv fluid flow back and forth between the primary and secondary infusion bags.There was no patient harm.

• 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: 8291688
• MDR Text Key: 134560665
• Report Number: 9616066-2019-00280
• 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,Followup,Followup
• Report Date: 01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 72213N, TD (B)(6) 2019; 8100,8015,SEC TUBING, TD (B)(6) 2019; 8100,8015,SEC TUBING, TD: (B)(6) 2019.