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

Model Number 2420-0007

Device Problems False Alarm (1013); Infusion or Flow Problem (2964)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Date 05/18/2019

Event Type  Injury  

Manufacturer Narrative

Occupation-contracting and sourcing admin.Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the product be received for evaluation.Patient age and dob requested but not provided, however the customer stated that the patient was an adult patient.

Event Description

It was reported that the infusion nitroglycerin 50mg/5% dextrose 250ml glass bottle tubing set was placed into the primary pump module while being piggybacked into a running primary infusion of 0.9% nacl infusing at a rate of 100ml/hour.The nitroglycering glass bottle was spiked, the tubing set vented and primed without difficulty.The nitroglycerin infusion was initiated at a rate of 10mcg/minute which is the facilities standard starting rate on an adult patient.Immediately after the infusion was initiated the device alarmed "occluded patient side" while the primary infusion tubing set displayed no occlusions.The secondary tubing set clamps were checked and found to be open.This was confirmed by a second rn.Suspecting that the tubing set was faulty, the rn disconnected the secondary tubing set from the primary tubing set and held it over a waste basket and restarted the pump module.The device continued to alarm "occluded patient side"' despite the secondary tubing set being disconnected.The secondary tubing set was removed from the pump module with the safety clamp opened and it was found that the nitroglycerin proceeded to flow freely.This was repeated with two other tubing sets, testing each set in two different pump channels only to have the devices to continue to alarm "occluded patient side." the nacl was infusing via channel a and the nitroglycerin was tried on channels b and c.No extension tubing sets were used.The patient remained slightly hypertensive immediately post-operatively.Although there was no direct harm immediately noticed, an order was eventually obtained for the initiation of a nicardipine infusion.

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Type of Device: SET, ADMINISTRATION, INFUSION
• 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: sylvia ventura ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 8707498
• MDR Text Key: 148287405
• Report Number: 9616066-2019-01669
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203021012
• UDI-Public: 7613203021012
• 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,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/10/2021
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Device Lot Number: 18033007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/10/2018
• 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
• Treatment: (3)8100,8015, THERAPY DATE: (B)(6) 2019
• Patient Outcome(s): Required Intervention