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

Model Number	10013361
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: 100 ml b braun bag, ref (b)(4), ndc 0264-1800-32.No product returned.Because no product was returned or expected to be returned, no failure investigation could be performed.The root cause of the customer's experience was not identified.Patient age and dob requested but not provided.
Event or Problem Description
It was reported that the tubing set spike unintentionally disconnected from the chemotherapy infusion bag causing a significant loss of medication.The customer further stated that there were no adverse effects caused to the patient from the event.
Event or Problem Description
It was reported that the tubing set spike unintentionally disconnected from the chemotherapy infusion bag causing a significant loss of medication.The customer further stated that there were no adverse effects caused to the patient from the event.
Additional Manufacturer Narrative
Correction: demographics requested but not provided.The customer¿s report that the tubing set spike unintentionally disconnected during an infusion was not confirmed.The suspect event set (model 10013361, lot 19036336) that was in use at the time of the event was not returned for investigation.Received from the customer was one unopened associate primary set model 10013361 with lot number 19045188.No anomalies noted upon visual inspection.Functional, infusion testing with a lab pump module, and pressure testing also found no leaking, alarms, disconnections or issues with the returned set.The root cause of the disconnection of the spike from the iv bag was not identified.
Event or Problem Description
It was reported that the tubing set spike unintentionally disconnected from the chemotherapy infusion bag causing a significant loss of medication.The customer further stated that there were no adverse effects caused to the patient from the event.
Additional Manufacturer Narrative
Additional patient information: diagnosis; lung cancer.

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INFUSION
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8881184
• Report Number: 9616066-2019-02224
• Device Sequence Number: 16826981
• Product Code: FPA
• UDI-Device Identifier: 10885403221965
• UDI-Public: 10885403221965
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 07/16/2019

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 Expiration Date: 03/20/2022
• Device Model Number: 10013361
• Device Catalogue Number: 10013361
• Device Lot Number: 19036336
• 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: 08/09/2019
• Supplement Report FDA Received Date: 08/18/2019; 09/10/2019
• 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: 100 ML B BRAUN BAG REF (B)(4) NDC 0264-1800-32; 8015,8100,THERAPY DATE UNKNOWN; TD (B)(6) 2019
• Patient Age: 72 YR
• Patient Weight: 80