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

Model Number	10015862
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 not returned for failure investigation.The root cause of this failure was not identified.
Event or Problem Description
It was reported that tubing leaked during an infusion of carboplatin (chemotherapy).The leak was detected in the iv tubing at the end portion of the non-vented drip chamber.Chemo was spilled onto the floor, patient's chair, the iv pole, as well as the patient's personal items.Although requested, additional information was not provided.
Additional Manufacturer Narrative
Photo provided by the customer observed that the tubing had a slice cut right below the drip chamber outlet port.The root cause of this failure was not identified.Device history record for model 10015862 lot 20045168 shows that the set was manufactured on 1 april 2020 with a total of 3,843 units.There were no qn¿s (quality notification) issued during the production build of this lot for the failure mode reported.
Event or Problem Description
It was reported that tubing leaked during an infusion of carboplatin (chemotherapy).The leak was detected in the iv tubing at the end portion of the non-vented drip chamber.Chemo was spilled onto the floor, patient's chair, the iv pole, as well as the patient's personal items.Although requested, additional information was 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: 10099222
• Report Number: 9616066-2020-01757
• Device Sequence Number: 3387239
• Product Code: FPA
• UDI-Device Identifier: 10885403221866
• UDI-Public: 10885403221866
• 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): 05/07/2020

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 Expiration Date: 04/01/2023
• Device Model Number: 10015862
• Device Catalogue Number: 10015862
• Device Lot Number: 20045168
• 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: 05/28/2020
• Supplement Report FDA Received Date: 08/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1