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

Model Number	10012143
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Additional patient information: ethnicity: not hispanic/latino, race: white.
Event or Problem Description
Received a copy of the customer's medsun report from the fda which states, ¿female at (b)(6) gestation presented with contractions getting stronger since midnight.Patient tubing on iv set appeared to have broken right above y connection.Nurse able to clamp it off and call for help and change out the iv.The medsun provided additional information under "what was the original intended procedure?: tubing broke right above y connection.Nurse was in room and pt.Stated that her iv came undone.Nurse was in room and patient stated her iv had come undone.Nurse went to bedside and clamped tubing to avoid blood loss and called for help.The original tubing had not ever been clamped at this "broken" section of tubing.No harm to patient, no est blood loss." an incomplete date of event of (b)(6) 2019 was provided.
Additional Manufacturer Narrative
The customer¿s report that the tubing broke right above y connection and leaked was confirmed to be a separation.Visual inspection identified a separation near the base of the y-split between the tubing (p/n 605518-000) and tubing (p/n 660134).Microscopic inspection of the tubing found insufficient solvent at the separation site.Further functional testing could not be performed due to the separation and obvious leaking that would occur at the separation.The tubing diameter was noted to be within iso-specification.The root cause of the separation is due to insufficient solvent during the manufacturing process.
Event or Problem Description
Received a copy of the customer's medsun report from the fda which states, ¿female at full term gestation presented with contractions getting stronger since midnight.Patient tubing on iv set appeared to have broken right above y connection.Nurse able to clamp it off and call for help and change out the iv.The medsun provided additional information under "what was the original intended procedure?: tubing broke right above y connection.Nurse was in room and patient stated her iv had come undone.Nurse went to bedside and clamped tubing to avoid blood loss and called for help.The original tubing had not ever been clamped at this "broken" section of tubing.No harm to patient, no est blood loss." an incomplete date of event of (b)(6) 2019 was provided.It was reported that during a primary infusion of lactated ringers 1000ml at 125ml/hour and another primary infusion of oxytocin 30 units/500ml being titrated for uterine contractions, the tubing set leaked at the y-site.The nurse was at the patient's bedside when the leak occurred and prevented the patient from bleeding.The event occurred in the labor and delivery department.There was no blood loss, and no patient harm.
Event or Problem Description
Received a copy of the customer's medsun report from the fda which states, ¿female at full term gestation presented with contractions getting stronger since midnight.Patient tubing on iv set appeared to have broken right above y connection.Nurse able to clamp it off and call for help and change out the iv.The medsun provided additional information under "what was the original intended procedure?: tubing broke right above y connection.Nurse was in room and pt.Stated that her iv came undone.Nurse was in room and patient stated her iv had come undone.Nurse went to bedside and clamped tubing to avoid blood loss and called for help.The original tubing had not ever been clamped at this "broken" section of tubing.No harm to patient, no est blood loss." an incomplete date of event of jan-2019 was provided.It was reported that during a primary infusion of lactated ringers 1000ml at 125ml/hour and another primary infusion of oxytocin 500ml being titrated for uterine contractions, the tubing set leaked at the y-site.The nurse was at the patient's bedside when the leak occurred and prevented the patient from bleeding.The event occurred in the labor and delivery department.There was no blood loss, and no patient harm.
Additional Manufacturer Narrative
Changed reportable malfunction to serious injury.

• Brand Name: ALARIS EXTENSION SET
• Common Device Name: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8420354
• Report Number: 9616066-2019-00689
• Device Sequence Number: 16656887
• Product Code: FPA
• UDI-Device Identifier: 10885403233661
• UDI-Public: 10885403233661
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/22/2019

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
• Operator of Device: Health Professional
• Device Model Number: 10012143
• Device Catalogue Number: 10012143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/14/2019
• Supplement Report FDA Received Date: 04/25/2019; 05/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: C24104E,8015,8100,TD (B)(6) 2019.; C24104E,8015,8100.; NON-BD CONNECTOR, THERAPY DATE UNKNOWN.; NON-BD CONNECTOR, THERAPY DATE UNKNOWN
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 19 YR
• Patient Weight: 90