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

Model Number	10796812
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: 250ml braun bag, lot: j9n180, exp: 10/21, 0.9% sodium chloride injection; bd catheter; td 01/01/2020 no product will be returned per customer because the product was discarded.Although requested, no additional patient demographics were provided.
Event or Problem Description
It was reported that there was a gravity tubing leak.The event occurred on a pet/ct unit, during an administration of "f18 fluorodeoxyglucose (radioactive fluorine)," given with 21 gauge needle using 3 ml syringe.There was no patient harm or adverse effects as a result of this event.The event did not cause a significant change in course of treatment for the patient, nor require medical or surgical intervention as a result.There was no user harm.
Additional Manufacturer Narrative
The customer¿s report of a gravity tubing leak at the injection port was confirmed on the gravity set model by the received customer provided photo.Suspect set model was not received for investigation.Received from the customer was one used gravity set.Clear liquid was observed in the used set¿s drip chamber and entire length of tubing.No abnormalities were observed on the sets during visual inspection.Functional testing showed no anomalies.The root cause of the customer¿s observed event was not identified.
Event or Problem Description
It was reported that there was a gravity tubing leak.The event occurred on a pet/ct unit, during an administration of "f18 fluorodeoxyglucose (radioactive fluorine)," given with 21 gauge needle using 3 ml syringe.There was no patient harm or adverse effects as a result of this event.The event did not cause a significant change in course of treatment for the patient, nor require medical or surgical intervention as a result.There was no user harm.
Event or Problem Description
It was reported that there was a gravity tubing leak.The event occurred on a pet/ct unit, during an administration of "f18 fluorodeoxyglucose (radioactive fluorine)," given with 21 gauge needle using 3 ml syringe.There was no patient harm or adverse effects as a result of this event.The event did not cause a significant change in course of treatment for the patient, nor require medical or surgical intervention as a result.There was no user harm.
Additional Manufacturer Narrative
The customer¿s report of a gravity tubing leak at the injection port was confirmed on gravity set by the received customer provided photo.Suspect set model 10796812 lot unknown, was not received for investigation.The root cause of the customer¿s observed event was not identified.

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Common Device Name: SET,ADMINISTRATION,INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9717428
• Report Number: 9616066-2020-00459
• Device Sequence Number: 13541488
• Product Code: FPA
• UDI-Device Identifier: 10885403234316
• UDI-Public: 10885403234316
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K820278
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/28/2020

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: 10796812
• Device Catalogue Number: 10796812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 02/17/2020
• Supplement Report FDA Received Date: 04/16/2020; 04/25/2020
• 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: 21 GAUGE NEEDLE,3ML SYRINGE, TD (B)(6) 2020
• Patient Age: 39 YR
• Patient Weight: 103