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

Model Number 2426-0007

Device Problem Free or Unrestricted Flow (2945)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Date 05/29/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical product: 250 ml baxter bag, lot y298372, exp aug 20, 0.9% sodium chloride injection.The customer¿s report of free-flow of 250ml of levophed within 2 minutes was confirmed and replicated.Testing of the set¿s roller clamp, pinch clamp, and pump segment safety clamp verified the clamps performed correctly.The lab pump module door was opened and closed multiple times to test the pump module safety clamp operation.It was observed that the clamp performed correctly and closed completely when the pump module door was opened.The set was then tested with the roller clamp open and the safety clamp 3/4 open (per the customer description), and the combination of clamp positions produced a free-flow event, confirming the customer's complaint.A measurement analysis of the set¿s silicone segment component was within specification.The root cause was identified as the combination of the set¿s roller clamp being in the open position and the pump segment safety clamp being 3/4 open.

Event Description

It was reported that levophed 250ml free-flowed within 2 minutes in the cticu.As the clinician was removing the iv tubing from the pump while still attached to the patient, the safety clamp was found to be 3/4 of the way open, and the roller clamp was not engaged prior to removal of the medication and tubing from the pump.The patient experienced an episode of hypertension, requiring the administration of labetalol.There was no report of lasting harm.The facility's unit clinician and staff used the set once it was discontinued from the patient to try to replicate the situation and they were unable to replicate the event.They tried inserting and removing over 20 times, and it did not fail.

• 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: 8739377
• MDR Text Key: 149352864
• Report Number: 9616066-2019-01677
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403227998
• UDI-Public: 10885403227998
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2019
• 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: 06/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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: 8100,8015, THERAPY DATE: (B)(6) 2019
• Patient Outcome(s): Required Intervention