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

Model Number	10013890
Medical Device Problem Codes	Fluid/Blood Leak (1250); Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.Additional information including patient's demographics requested, but was not provided.
Event or Problem Description
It was reported that the iv tubing set appeared to have micro holes where fluid seemed to be seeping from the tubing where the cartridge is inserted into pump.
Event or Problem Description
It was reported that the iv tubing set appeared to have micro holes where fluid seemed to be seeping from the tubing where the cartridge is inserted into pump.
Additional Manufacturer Narrative
Correction on initial report: g.3 (disregard other & not provided).

• 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: 10046525
• Report Number: 9616066-2020-01557
• Device Sequence Number: 19528707
• Product Code: FPA
• UDI-Device Identifier: 10885403232268
• UDI-Public: 10885403232268
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2020

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: 10013890
• Device Catalogue Number: 10013890
• 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: 05/12/2020
• Supplement Report FDA Received Date: 05/18/2020
• 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: 8015,8100, THERAPY DATE UNK