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

Model Number 2447-0007

Device Problems Crack (1135); Fluid/Blood Leak (1250); Insufficient Flow or Under Infusion (2182)

Patient Problem Electrolyte Imbalance (2196)

Event Date 12/22/2018

Event Type  Injury  

Manufacturer Narrative

Patient was an infant (nicu).No other demographics were provided.Cont concomitant medical products: non bd set, bag 4, 2 non-bd swab caps.The customer's report of crack and leak near the upper fitment was confirmed.Visual inspection identified a 0.1215 inch tear in the upper silicone segment near the upper fitment.Microscopic inspection noted a crush mark to the upper fitment.Functional and pressure testing confirmed the leak in the same location.The root cause of the tear could not be determined.

Event Description

The customer reported that the smartsite burette infusion set cracked near the upper fitment and leaked tpn in the nicu; as a result, the infant did not receive their scheduled tpn dose.A note attached to the received product stated the tubing was punctured inside the pump, and noticed when the pump was being cleared.The infant received a full iv fluid and tubing change, as well as a dose of prophylactic vancomycin.

• 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
• Manufacturer (Section G): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: mustafa omar ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 8276695
• MDR Text Key: 134059845
• Report Number: 9616066-2019-00150
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403235078
• UDI-Public: 10885403235078
• 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,distri
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2447-0007
• Device Catalogue Number: 2447-0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/24/2019
• 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: 8015,8100,TD (B)(6) 2018
• Patient Outcome(s): Required Intervention