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

Model Number 30914

Device Problem Fluid/Blood Leak (1250)

Patient Problems Apnea (1720); Bradycardia (1751); Underdose (2542)

Event Date 12/20/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical product: microclave, therapy date: (b)(6) 2018.Apnea and bradycardia episodes due to prematurity.Premature infant; patient was a twin that was born at 28 week 5 days; this is the corrected gestational age in medwatch additional information.Patient was 6 days old documented on mw however customer corrected gestational age to 28 week 5 days.Patient on ram cpap for ventilation and oxygenation.Not hispanic/latino.Race- black or african american.Weight (b)(6) documented on medwatch without the units, the customer confirmed the patient weight is in grams.(b)(6) -documented as (b)(6).Apnea and bradycardia episodes due to prematurity.The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.

Event Description

Received a copy of the customer's medwatch report from the fda which states, "preterm infant was receiving cafcit (caffeine citrate} iv every 12 hours for apnea and bradycardia episodes due to prematurity.Rn gave dose on at 2118 and noted that patient was having increased episodes of apnea and bradycardia in which the infant required mild stimulation to recover.Rn then noticed that the iv tubing was wet on the exterior and changed the iv tubing.She then attempted to flush the line and noted that there was leaking at the hub of the tubing.Infant most likely did not receive entire dose of cafcit at 2118." an incomplete date of event of (b)(6) 2018 was provided.Intended procedure: infusion of central nervous system stimulant to preterm infant to prevent apnea and bradycardia episodes.The event occurred in the nicu.The customer later reported that a gentle touch of the infant assisted the patient to recover from the apnea and bradycardia.The patient was currently still in the nicu due to the extreme premature birth as of (b)(6) 2019.It was reported that the set was in use for less than 24 hrs.The cafcit (caffeine citrate) infusion was initiated on (b)(6) at 2225pm.

Manufacturer Narrative

The customer¿s report of leaking at the hub of the tubing was not confirmed.Visual inspection of the set noted no damage or any anomalies.The connections were secure.Functional testing via syringe flow, lab syringe pump infusion test, and submerged pressure testing resulted in the set flowing freely and no leaking occurred.The root cause of the customer¿s report of a leaking set was not identified.

Event Description

Received a copy of the customer's medwatch report from the fda which states, "preterm infant was receiving cafcit (caffeine citrate} iv every 12 hours for apnea and bradycardia episodes due to prematurity.Rn gave dose on at 2118 and noted that patient was having increased episodes of apnea and bradycardia in which the infant required mild stimulation to recover.Rn then noticed that the iv tubing was wet on the exterior and changed the iv tubing.She then attempted to flush the line and noted that there was leaking at the hub of the tubing.Infant most likely did not receive entire dose of cafcit at 2118." an incomplete date of event of (b)(6) 2018 was provided.Intended procedure: infusion of central nervous system stimulant to preterm infant to prevent apnea and bradycardia episodes.The event occurred in the nicu.The customer later reported that a gentle touch of the infant assisted the patient to recover from the apnea and bradycardia.The patient was currently still in the nicu due to the extreme premature birth as of (b)(6) 2019.It was reported that the set was in use for less than 24 hrs.The cafcit (caffeine citrate) infusion was initiated on (b)(6) at 2225pm.

• Brand Name: MICROBORE EXTENSION SET
• Type of Device: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8321326
• MDR Text Key: 135569516
• Report Number: 9616066-2019-00301
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403233319
• UDI-Public: 10885403233319
• Combination Product (y/n): N
• PMA/PMN Number: K790108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/15/2019

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 Expiration Date: 02/03/2021
• Device Model Number: 30914
• Device Catalogue Number: 30914
• Device Lot Number: 18025196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/08/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 30914; 8015,8110,SYR TUBE,IV FLUSH,SYRINGE, TD (B)(6) 2018; 8015,8110,SYR TUBE,IV FLUSH,SYRINGE, TD: (B)(6) 2018
• Patient Outcome(s): Required Intervention
• Patient Age: 5 DA
• Patient Weight: 1