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

Model Number	10013072
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: bag access spike clave; bag spike adapter.Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.Per customer, it is (b)(6) policy not to provide patient information.
Event or Problem Description
It was reported that the iv pump alarmed infusion complete for chemotherapy taxol with total volume of 595ml.It was noted that the intended rate of infusion was 180-190ml/hr and was programmed using guardrails drug library.When the nurse attended to the patient, it was found that 100ml of the medication was still left in the bag.The remaining volume was eventually infused until the bag was dry.There was no patient harm.
Event or Problem Description
It was reported that the iv pump alarmed infusion complete for chemotherapy taxol with total volume of 595ml.It was noted that the intended rate of infusion was 180-190ml/hr and was programmed using guardrails drug library.When the nurse attended to the patient, it was found that 100ml of the medication was still left in the bag.The remaining volume was eventually infused until the bag was dry.There was no patient harm.
Additional Manufacturer Narrative
Cont'd from d.11: spiros adapter: the customer¿s report that medication was still left in the bag after pump alarmed infusion complete was not confirmed.The sets were visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Visual inspection of the set noted no damage or any anomalies.Functional testing resulted in no alarms or any other issues.Results indicate that the device is within specification and the primary set infused at the correct rate.Dimensional analysis was performed and found the primary and secondary set¿s tubing measured to be within specification(s).The root cause of the reported medication still left in the bag was not determined.

• 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: 9417910
• Report Number: 9616066-2019-03557
• Device Sequence Number: 484733
• Product Code: FPA
• UDI-Device Identifier: 07613203021210
• UDI-Public: 7613203021210
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2019

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 Model Number: 10013072
• Device Catalogue Number: 10013072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 03/09/2020
• 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: 10013902, 8100, 8015, THERAPY DATE: (B)(6) 2019.; BAXTER 25ML 0.9% NACL (SODIUM CHLORIDE) BAG