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

Model Number	10013361
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, the affected product has not been received.A follow up report will be submitted with investigation results should the devices be received for evaluation.
Event or Problem Description
Received a copy of the customer's medwatch report which states, "patient's etoposide infusion line leaking under pump segment portion of the tubing approximately 40 minutes into the infusion with 20 minutes remaining.Infusion was stopped immediately and a chemo spill kit was utilized.An estimated 321.1 ml should have been infused with 178.9 ml remaining.There was approximately 100 ml of a spill estimated, estimating that the patient received around 221.1 ml.The patient was removed from vicinity.Etoposide infusion bag walked to pharmacy with proper safety measures taken.Md, pharmacy, supervisor notified." there was no report of patient harm.
Additional Manufacturer Narrative
Additional information provide from mw5081736.
Event or Problem Description
Received a copy of the customer's sus voluntary event report which states, "patient's etoposide infusion line leaking under pump segment portion of the tubing approximately 40 minutes into the infusion with 20 minutes remaining.Infusion was stopped immediately and a chemo spill kit was utilized.An estimated 321.1 ml should have been infused with 178.9 ml remaining.There was approximately 100 ml of a spill estimated, estimating that the patient received around 221.1 ml.The patient was removed from vicinity.Etoposide infusion bag walked to pharmacy with proper safety measures taken.Md, pharmacy, supervisor notified.".
Additional Manufacturer Narrative
The affected product has been received and the evaluation is pending.A follow up report will be submitted once the evaluation is completed.
Event or Problem Description
Received from the customer a copy of the medwatch report which states, "patient's etoposide infusion line leaking under pump segment portion of the tubing approximately 40 minutes into the infusion with 20 minutes remaining.Infusion was stopped immediately and a chemo spill kit was utilized.An estimated 321.1 ml should have been infused with 178.9 ml remaining.There was approximately 100 ml of a spill estimated, estimating that the patient received around 221.1 ml.The patient was removed from vicinity.Etoposide infusion bag walked to pharmacy with proper safety measures taken.Md, pharmacy, supervisor notified." there was no report of patient harm.Received from the fda a copy of the customer's sus voluntary event report which states, "patient's etoposide infusion line leaking under pump segment portion of the tubing approximately 40 minutes into the infusion with 20 minutes remaining.Infusion was stopped immediately and a chemo spill kit was utilized.An estimated 321.1 ml should have been infused with 178.9 ml remaining.There was approximately 100 ml of a spill estimated, estimating that the patient received around 221.1 ml.The patient was removed from vicinity.Etoposide infusion bag walked to pharmacy with proper safety measures taken.Md, pharmacy, supervisor notified.".
Additional Manufacturer Narrative
The customer¿s report that the tubing leaked at the pump segment was confirmed.Visual inspection observed that the silicone segment had a tear near the upper fitment.The tear measured 0.0465 inch long.Visual examination under magnification noted no crush marks to the upper blue fitment.No other anomalies were noted.During functional testing a leak was observed coming from the silicone tubing near the upper fitment.It was reported that the leak was noted approximately 40 minutes into the 60 minute infusion.The cause of the leak was a tear in the silicone segment.A root cause for the observed tear, or a determination as to when it occurred, could not be determined.
Event or Problem Description
Received from the customer a copy of the medwatch report which states, "patient's etoposide infusion line leaking under pump segment portion of the tubing approximately 40 minutes into the infusion with 20 minutes remaining.Infusion was stopped immediately and a chemo spill kit was utilized.An estimated 321.1 ml should have been infused with 178.9 ml remaining.There was approximately 100 ml of a spill estimated, estimating that the patient received around 221.1 ml.The patient was removed from vicinity.Etoposide infusion bag walked to pharmacy with proper safety measures taken.Md, pharmacy, supervisor notified." there was no report of patient harm.Received from the fda a copy of the customer's sus voluntary event report which states, "patient's etoposide infusion line leaking under pump segment portion of the tubing approximately 40 minutes into the infusion with 20 minutes remaining.Infusion was stopped immediately and a chemo spill kit was utilized.An estimated 321.1 ml should have been infused with 178.9 ml remaining.There was approximately 100 ml of a spill estimated, estimating that the patient received around 221.1 ml.The patient was removed from vicinity.Etoposide infusion bag walked to pharmacy with proper safety measures taken.Md, pharmacy, supervisor notified.".

• 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: 8157794
• Report Number: 9616066-2018-02475
• Device Sequence Number: 1721419
• Product Code: FPA
• UDI-Device Identifier: 10885403221965
• UDI-Public: 10885403221965
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,user faci
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/19/2018

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: 08/16/2021
• Device Model Number: 10013361
• Device Catalogue Number: 10013361
• Device Lot Number: 18086215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 12/12/2018
• Supplement Report FDA Received Date: 12/20/2018; 01/08/2019; 04/02/2019
• 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, TD (B)(6) 2018
• Patient Age: 74 YR
• Patient Weight: 76