MAUDE Adverse Event Report: CAREFUSION ALARIS EXTENSION SET; SET, EXTENSION, INTRAVASCULAR

Model Number 20029E

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/10/2018

Event Type  malfunction  

Manufacturer Narrative

Although requested, the affected product has not been received.A follow up report will be submitted with investigation results should the devices be received for evaluation.

Event Description

The customer reported that during a prn medication infusion on a syringe pump, a tubing leaked via the syringe/syringe tubing junction.There was no patient harm.

Event Description

The customer reported that during a prn medication infusion on a syringe pump, a tubing leaked via the syringe/syringe tubing junction.There was no patient harm.

Manufacturer Narrative

No product will be returned per customer.The customer complaint could not be confirmed because the product was not returned for failure investigation.The root cause of this failure was not identified.

Event Description

The customer reported that during a prn medication infusion on a syringe pump, a tubing leaked via the syringe/syringe tubing junction.There was no patient harm.

Manufacturer Narrative

Correction on follow-up(1): a.2 (disregard date of birth).

• Brand Name: ALARIS EXTENSION SET
• Type of Device: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 7887822
• MDR Text Key: 120695768
• Report Number: 9616066-2018-01740
• Device Sequence Number: 1
• Product Code: FPB
• UDI-Device Identifier: 10885403234866
• UDI-Public: 10885403234866
• Combination Product (y/n): N
• PMA/PMN Number: K801614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 08/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20029E
• Device Catalogue Number: 20029E
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 2000E,NON-BD EXT SET,3ML SYRINGE; 8015,8110,30914,SYRINGE, THERAPY DATE (B)(6) 2018
• Patient Age: 4 YR
• Patient Weight: 15