MAUDE Adverse Event Report: CAREFUSION PRESSURE RATED EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	MPX5302-C
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product will be returned per customer.The customer complaint could not be confirmed because the product was discarded and not returned for failure investigation.The root cause of this failure was not identified.Sections were requested but not provided.
Event or Problem Description
It was reported that the extension tubing set leaked under the opsite at the connection to the patient's iv site during a blood transfusion.The opsite had to be replaced.The leak continued despite attempts at tightening the connection.The extension set was removed and a straight connection was made between the blood administration tubing and the patient's iv site.The customer does not think that leaving the extension set off during a blood transfusion is safe, so they decided to add a needleless connector to the patient's iv site in the event if another leak should occur.There were no adverse effects caused to the patient from the event.
Additional Manufacturer Narrative
Correction on initial report: b.5 & d.4.
Event or Problem Description
It was reported from the infusion center that the extension tubing set leaked under the opsite at the connection to the patient's iv site during a blood transfusion.The opsite had to be replaced.The leak continued despite attempts at tightening the connection.The extension set was removed and a straight connection was made between the blood administration tubing and the patient's iv site.The customer does not think that leaving the extension set off during a blood transfusion is safe, so they decided to add a needleless connector to the patient's iv site in the event if another leak should occur.There were no adverse effects caused to the patient from the event.
Event or Problem Description
It was reported from the infusion center that the extension tubing set leaked under the opposite at the connection to the patient's iv site during a blood transfusion.The opposite had to be replaced.The leak continued despite attempts at tightening the connection.The extension set was removed and a straight connection was made between the blood administration tubing and the patient's iv site.The customer does not think that leaving the extension set off during a blood transfusion is safe, so they decided to add a needleless connector to the patient's iv site in the event if another leak should occur.Although it was noted that there was a delay in treatment, it was further confirmed during follow up, however; that there was no patient harm or impact as a result of this event.
Additional Manufacturer Narrative
Additional information provided: section; b.5.(patient/event information clarified/detailed).The customer's report of extension tubing set leaked at connection to mating device was not confirmed.The extension set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Visual inspection of the set noted no damage or any anomalies.The set was then loaded into a lab pump module and the infusion completed with no occlusion alarms or leaks at any of the connections observed during the infusion.Pressure testing resulted in no leaks or disconnections.The extension sets ¿max-y¿ component and female/male luer ports were measured to be within iso standards.The root cause was not identified.

• Brand Name: PRESSURE RATED EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9745996
• Report Number: 9616066-2020-00450
• Device Sequence Number: 11216234
• Product Code: FPA
• UDI-Device Identifier: 10885403237225
• UDI-Public: 10885403237225
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MPX5302-C
• Device Catalogue Number: MPX5302-C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 02/24/2020
• Supplement Report FDA Received Date: 03/14/2020; 04/13/2020
• 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: JELCO,(2) NON-BD ORANGE CUROS CAPS.; PRI TUBING, THERAPY DATE UNK