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

Model Number	10800177
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/18/2019
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.
Event or Problem Description
Received a copy of the customer's medsun report from fda which states, ¿infusing levophed drip puddle noted on floor by the iv pump the actual amount in the iv bag should have been approximately 100 ml upon discovery, only 20 ml of levophed left in the iv bag fluid leakage for the iv tubing was likely above where the tubing is inserted into the iv pump there was no harm to the patient." an incomplete date of event of (b)(6) 2019 was provided.
Event or Problem Description
Received a copy of the customer's medsun report from fda which states, ¿infusing levophed drip puddle noted on floor by the iv pump the actual amount in the iv bag should have been approximately 100 ml upon discovery, only 20 ml of levophed left in the iv bag fluid leakage for the iv tubing was likely above where the tubing is inserted into the iv pump there was no harm to the patient." an incomplete date of event of (b)(6) 2019 was provided.The customer states, "review of the med watch document indicates the date of (b)(6) 2019 time is 5:45 am.".

• 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: 8898906
• Report Number: 9616066-2019-02249
• Device Sequence Number: 16497148
• Product Code: FPA
• UDI-Device Identifier: 10885403234422
• UDI-Public: 10885403234422
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K811885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2019

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: 10800177
• Device Catalogue Number: 10800177
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/15/2019
• Supplement Report FDA Received Date: 09/19/2019
• 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: 8120, 8015, TD UNK; 8120, 8015, TD UNK
• Patient Age: 69 YR