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

Model Number	10013361
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, the affected product has not been received.A follow up report will be submitted with investigation results should the devices be received for evaluation.
Event or Problem Description
The customer reported that the nurse initiated gemzar, a chemotherapy infusion and the tubing started to leak from the access port.The infusion was stopped and the spill was cleaned up.There was no harm caused to the patient from the event, however, the treatment was delayed due to the iv fluid having to be remade.
Additional Manufacturer Narrative
No product will be returned per customer.The customer complaint could not be confirmed because the product was not returned for failure investigation.The root cause of this failure was not identified.
Event or Problem Description
The customer reported that the nurse initiated gemzar, a chemotherapy infusion and the tubing started to leak from the bag access port.The infusion was stopped and the spill was cleaned up.There was no harm caused to the patient from the event, however, the treatment was delayed due to the iv fluid having to be remade.
Event or Problem Description
The customer reported that the nurse initiated gemzar, a chemotherapy infusion and the tubing started to leak from the bag access port.The infusion was stopped and the spill was cleaned up.There was no harm caused to the patient from the event, however, the treatment was delayed due to the iv fluid having to be remade.Received a copy of the customer's sus voluntary event report from the fda, which states "the nurse attempted to hang a pt's chemotherapy infusion.The drug was started and began leaking from the smartsite bag access port that had a red cover on it at the injection site underneath bag.About 4-5 drops were noted leaking through the port.The infusion was stopped and a chemo spill kit retrieved and used.Drug sent back to pharmacy.".

• 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: 7902907
• Report Number: 9616066-2018-01748
• Device Sequence Number: 165231
• 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: health professional,user faci
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/04/2018

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 Expiration Date: 12/09/2020
• Device Model Number: 10013361
• Device Catalogue Number: 10013361
• Device Lot Number: 17125396
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 09/24/2018
• Supplement Report FDA Received Date: 09/28/2018; 10/16/2018
• 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; THERAPY DATE (B)(6) 2018; 8015,8100, THERAPY DATE UNK
• Patient Age: 65 YR
• Patient Weight: 61