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

Model Number PRI TUBING

Device Problem Backflow (1064)

Patient Problem Missed Dose (2561)

Event Date 02/09/2020

Event Type  malfunction  

Manufacturer Narrative

No product will be returned per customer.The product was discarded and not returned for failure investigation.Although requested, information and race and ethnicity were not provided.

Event Description

It was reported that an unspecified 100ml antibiotic secondary infusion (yellow in color) back flowed into the primary bag of 500ml 0.9% sodium chloride (clear in color).The customer provided a photo of the involved products where in the primary bag of sodium chloride turned into yellowish in color.The secondary bag was empty.The patient consequently did not receive the medication dose as the clinician was unsure how much volume was actually been administered.The event occurred in pediatric medicine unit.There was no serious injury but there was a delay in infusion therapy.The physician was notified and subsequent readjustment of the medication schedule was done.

Manufacturer Narrative

The customer¿s report of back flow was confirmed by visual inspection of the customer-provided photo of the suspect set.Further evaluation of the photo observed that the yellow fluid flowed based the primary set¿s check valve.The root cause of this failure was not identified as no product was returned.

Event Description

It was reported that an unspecified 100ml antibiotic secondary infusion (yellow in color) back-flowed into the primary bag of 500ml 0.9% sodium chloride (clear in color).The customer provided a photo of the involved products where in the primary bag of sodium chloride turned into yellowish in color.The secondary bag was empty.The patient consequently did not receive the medication dose as the clinician was unsure how much volume was actually administered.The event occurred in the pediatric medicine unit.There was no serious injury but there was a delay in infusion therapy.The physician was notified and subsequent readjustment of the medication schedule was done.

• 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: 9926086
• MDR Text Key: 194125123
• Report Number: 9616066-2020-01178
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PRI TUBING
• Device Catalogue Number: PRI TUBING
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8015,SEC TUBING,8100, TD (B)(6) 2020.
• Patient Age: 17 YR
• Patient Weight: 50