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

Model Number	10015862
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Information (3190)
Date of Event	01/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: b braun teva syringe adapter/b braun teva luer lock adapter.No product will be returned per customer.The customer complaint could not be confirmed because the product was discarded and not returned for failure investigation.The root cause of this failure was not identified.
Event or Problem Description
It was reported that there was a chemo spill in the outpatient infusion center.The patient required a second infusion due to the doctor not know exactly how much the patient did not receive.The hazardous drug precautions were used for this spill.It is unclear to the staff if the issue was fault of the bd primary short set, or the b braun teva luer lock adapter or the teva syringe adapter not staying on the bd tubing.A puddle of chemo was noticed on the floor under the alaris pump.
Additional Manufacturer Narrative
Correction to:b4.
Event or Problem Description
It was reported that there was a albumin-bound docetaxel (chemotherapy) spill that was infusing through a shorter primary set attached to another primary set infusing 0.9% normal saline.There was possible aerosolized chemotherapy exposure.The affected patient, as well as other patients and nurses, were evacuated from the infusion suite per protocol.Based on the observation of amount of chemotherapy on the floor, the tubing leaked at connection site between the shorter tubing with the other tubing below the pump.The leak occurred slowly during infusion.After hazardous drug precautions were used to clean up the spill, the patient required a second infusion of chemotherapy due to the doctor not knowing exactly how much the patient did not receive.Patient was discharged after receiving the second bag and remainder of prescribed chemotherapy regiment.There were no serious injuries caused to any patients or nurses from the event.
Additional Manufacturer Narrative
Continued from d11-b braun teva syringe adapter;b braun teva luer lock adapter additional information added to: a2,a3,a4,b3,b7,d4,h4.****************************************************************************************.
Event or Problem Description
It was reported that there was a albumin-bound docetaxel (chemotherapy) spill that was infusing through a shorter primary set attached to another primary set infusing 0.9% normal saline.There was possible aerosolized chemotherapy exposure.The affected patient, as well as other patients and nurses, were evacuated from the infusion suite per protocol.Based on the observation of amount of chemotherapy on the floor, the tubing leaked at connection site between the shorter tubing with the other tubing below the pump.The leak occurred slowly during infusion.After hazardous drug precautions were used to clean up the spill, the patient required a second infusion of chemotherapy due to the doctor not knowing exactly how much the patient did not receive.Patient was discharged after receiving the second bag and remainder of prescribed chemotherapy regiment.There were no serious injuries caused to any patients or nurses from the event.
Event or Problem Description
It was reported that there was a albumin-bound docetaxel (chemotherapy) spill that was infusing through a shorter primary set attached to another primary set infusing 0.9% normal saline.There was possible aerosolized chemotherapy exposure.The affected patient, as well as other patients and nurses, were evacuated from the infusion suite per protocol.Based on the observation of amount of chemotherapy on the floor, the tubing leaked at connection site between the shorter tubing with the other tubing below the pump.The leak occurred slowly during infusion.After hazardous drug precautions were used to clean up the spill, the patient required a second infusion of chemotherapy due to the doctor not knowing exactly how much the patient did not receive.Patient was discharged after receiving the second bag and remainder of prescribed chemotherapy regiment.There were no serious injuries caused to any patients or nurses from the event.
Additional Manufacturer Narrative
The customer complaint of tubing leak could not be confirmed due to the product was not returned for failure investigation.A photo provided of the infusion set connection was provided by the customer.However, no leaks could be observed per photo provided by customer.The root cause of this failure was not identified as no product was returned.
Event or Problem Description
It was reported that there was a albumin-bound docetaxel (chemotherapy) spill that was infusing through a shorter primary set attached to another primary set infusing 0.9% normal saline.There was possible aerosolized chemotherapy exposure.The affected patient, as well as other patients and nurses, were evacuated from the infusion suite per protocol.Based on the observation of amount of chemotherapy on the floor, the tubing leaked at connection site between the shorter tubing with the other tubing below the pump.The leak occurred slowly during infusion.After hazardous drug precautions were used to clean up the spill, the patient required a second infusion of chemotherapy due to the doctor not knowing exactly how much the patient did not receive.Patient was discharged after receiving the second bag and remainder of prescribed chemotherapy regiment.There were no serious injuries caused to any patients or nurses from the event.
Additional Manufacturer Narrative
******correction to: e2=yes, e3=nurse, g3=health professional (delete "other"), g4 for supplemental pr 353955 should be (b)(6) 2020 (not 30jan2020).********.
Event or Problem Description
It was reported that there was a albumin-bound docetaxel (chemotherapy) spill that was infusing through a shorter primary set attached to another primary set infusing 0.9% normal saline.There was possible aerosolized chemotherapy exposure.The affected patient, as well as other patients and nurses, were evacuated from the infusion suite per protocol.Based on the observation of amount of chemotherapy on the floor, the tubing leaked at connection site between the shorter tubing with the other tubing below the pump.The leak occurred slowly during infusion.After hazardous drug precautions were used to clean up the spill, the patient required a second infusion of chemotherapy due to the doctor not knowing exactly how much the patient did not receive.Patient was discharged after receiving the second bag and remainder of prescribed chemotherapy regiment.There were no serious injuries caused to any patients or nurses from the event.

• 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: 9712489
• Report Number: 9616066-2020-00503
• Device Sequence Number: 2482821
• Product Code: FPA
• UDI-Device Identifier: 10885403221866
• UDI-Public: 10885403221866
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 01/30/2020

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: 11/01/2022
• Device Model Number: 10015862
• Device Catalogue Number: 10015862
• Device Lot Number: 19115290
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 02/14/2020
• Supplement Report FDA Received Date: 03/04/2020; 03/12/2020; 03/17/2020; 03/19/2020; 04/20/2020
• 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: 10013889, THERAPY DATE UNKNOWN
• Patient Age: 66 YR
• Patient Weight: 63