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

Model Number	10015489
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Requested patient demographics however not provided.
Event or Problem Description
It was reported that during a cisplatin (172 mg) infusion at an unspecified rate, the device alarmed.Upon further examination a leak was noted at the safety clamp of the primary tubing.It was reported that the chemo leak did not reach the patient skin.There was no report of patient harm.
Additional Manufacturer Narrative
The customer¿s report of set leaking was confirmed.Visual inspection of the set noted that the silicone segment had a tear near the upper fitment.Examination under magnification noted no crush marks to the upper blue fitment or lower fitment.No other anomalies were noted.Functional and pressure testing confirmed leaking coming out from the silicone tubing near the upper fitment.The root cause of the tear could not be determined.
Event or Problem Description
It was reported that during a cisplatin (172 mg) infusion at an unspecified rate, the device alarmed.Upon further examination a leak was noted at the safety clamp of the primary tubing.It was reported that the chemo leak did not reach the patient skin.There was no report of patient harm.

• 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: 8448303
• Report Number: 9616066-2019-00809
• Device Sequence Number: 3056643
• Product Code: FPA
• UDI-Device Identifier: 07613203021050
• UDI-Public: 7613203021050
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 02/27/2019

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: 10/10/2021
• Device Model Number: 10015489
• Device Catalogue Number: 10015489
• Device Lot Number: 18105808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/25/2019
• Supplement Report FDA Received Date: 06/19/2019
• 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: 8100,8015, THERAPY DATE 3/5/19; 8100,8015, THERAPY DATE (B)(6) 2019