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

Model Number	10821753
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Per customer, the information :race and ethnicity are not available.
Event or Problem Description
It was reported that during an unspecified infusion therapy, leakage were observed on the burette set and 0.2 micron filter extension set.The infusion continued and completed the therapy.There was no patient harm and the leak did not cause harm to the healthcare provider.
Event or Problem Description
It was reported that during an infusion of a 24-hour protocol chemotherapy (etoposide, doxorubicin and vincristine in a single infusion), leakage was observed at the 0.2 micron filter extension set.It was noted that a burette set was also used during infusion and there was no leak observed in the burette.The infusion continued and completed the therapy.There was no patient harm and the leak did not cause harm to the healthcare provider.
Additional Manufacturer Narrative
Please disregard this manufacturer report number 9616066-2020-01942.The customer has clarified that the leak was observed just in model # 20027e and not in model # 10821753.The issue on model # 20027e was already captured in manufacturer report number 9616066-2020-01922.Device history record for model 20027e lot 20016601 shows that the set was manufactured on 23 january 2020 with a total of (b)(4) units.There were no qn¿s (quality notification) issued during the production build of this lot for the failure mode reported.Device history record for model 10821753 lot 20026322 shows that the set was manufactured on 17 february 2020 with a total of (b)(4) units.There were no qn¿s (quality notification) issued during the production build of this lot for the failure mode reported.

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Common Device Name: SET, ADMIN, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10171984
• Report Number: 9616066-2020-01942
• Device Sequence Number: 16682661
• Product Code: FPA
• UDI-Device Identifier: 07613203019187
• UDI-Public: 7613203019187
• 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: health professional,other
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2020

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: 02/17/2023
• Device Model Number: 10821753
• Device Catalogue Number: 10821753
• Device Lot Number: 20026322
• 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: 06/18/2020
• Supplement Report FDA Received Date: 07/09/2020
• 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 (B)(6) 2020
• Patient Age: 16 YR
• Patient Weight: 79