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

Model Number	10013890
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: 1000ml braun bag, lot: j9p758, exp: 05/22, cisplat, cytoxan, vepesid in 0.9% nacl injection; spike adapter.The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.
Event or Problem Description
It was reported that while going to hang the chemotherapy infusion 1l ns bag mixed with cisplatin, cytoxan, and vepesid, the primary tubing set spike broke.The chemotherapy drug spilled inside of the bag it was carried in, but did not spill outside of the carrier bag.This occurred at inpatient oncology.There was no patient involvement.
Event or Problem Description
It was reported that while going to hang the chemotherapy infusion 1l ns bag mixed with cisplatin, cytoxan, and vepesid, the primary tubing set spike broke.The chemotherapy drug spilled inside of the bag it was carried in, but did not spill outside of the carrier bag.This occurred at inpatient oncology.There was no patient involvement.
Additional Manufacturer Narrative
Correction: initially reportable but investigation determined defect on non-bd product.After further review this file is deemed not-reportable.

• 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: 10011280
• Report Number: 9616066-2020-01410
• Device Sequence Number: 2547189
• Product Code: FPA
• UDI-Device Identifier: 10885403232268
• UDI-Public: 10885403232268
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2020

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 Model Number: 10013890
• Device Catalogue Number: 10013890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/29/2020
• Supplement Report FDA Received Date: 07/29/2020
• 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: SPIROS ADAPTER,ALCOHOL CAP, TD (B)(6) 2020