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

Model Number	10013361
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	02/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer¿s report of the tubing set separated at the drip chamber could not be determined.The reported set model 10013361 that was in use during the customer event was discarded and not returned for failure investigation.Patient race: caucasian.
Event or Problem Description
It was reported that when placing the tubing set into the pump module before starting an infusion of an investigational non-chemotherapy drug to an adult patient, the tubing set separated at the drip chamber, and there was spillage of the medication.The event occurred at (b)(6).There was no report of an adverse effect on the patient.Customer advocacy received a copy of the customer's medwatch report which states, "pt was about to receive research drug (non-chemotherapy) while fixing tubing into chamber of pump, the tubing broke in half and an unk amount of drug spilled (pt did not receive any of the drug) research team notified, both research pharmacy and main pharmacy notified first bag of research drug disposed of per pharmacies advice new bag was mixed and started for pt about an hour delay in pt¿s overall treatment the iv line came apart above the pump segment fda safety report id# (b)(4).".

• 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: 9925279
• Report Number: 9616066-2020-01218
• Device Sequence Number: 3272434
• Product Code: FPA
• UDI-Device Identifier: 10885403221965
• UDI-Public: 10885403221965
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 03/11/2020

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: 10013361
• Device Catalogue Number: 10013361
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 62