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

Model Number	24602-B007T
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
Received a copy of the customer's medwatch report from fda, which states ¿the specialized iv tubing for vp-16 chemotherapy agent had a pin hole leak in the portion of the tubing that loads into the alaris pump cassette.The hole was not found upon visual inspection prior to loading the tubing, but it began to leak once the door to the cassette was closed.When i opened the door i saw a pin hole size opening approximately 0.5 cm below where the tubing connects to the adapter at the top.There was liquid spraying up and outwards to the patient's chair, the patient's upper arm, the floor and the sleeve of the gown nurse was wearing." an incomplete date of event of (b)(6) 2018 was provided.There was no report of patient harm.
Additional Manufacturer Narrative
Additional information provided: the medwatch report has a partial product expiration date of xx-jan-2021.
Event or Problem Description
Received a copy of the customer's medwatch report from fda, which states ¿the specialized iv tubing for vp-16 chemotherapy agent had a pin hole leak in the portion of the tubing that loads into the alaris pump cassette.The hole was not found upon visual inspection prior to loading the tubing, but it began to leak once the door to the cassette was closed.When i opened the door i saw a pin hole size opening approximately 0.5 cm below where the tubing connects to the adapter at the top.There was liquid spraying up and outwards to the patient's chair, the patient's upper arm, the floor and the sleeve of the gown nurse was wearing." an incomplete date of event of (b)(6) 2018 was provided.There was no report of patient harm.
Event or Problem Description
Received a copy of the customer's medwatch report from fda, which states ¿the specialized iv tubing for vp-16 chemotherapy agent had a pin hole leak in the portion of the tubing that loads into the alaris pump cassette.The hole was not found upon visual inspection prior to loading the tubing, but it began to leak once the door to the cassette was closed.When i opened the door i saw a pin hole size opening approximately 0.5 cm below where the tubing connects to the adapter at the top.There was liquid spraying up and outwards to the patient's chair, the patient's upper arm, the floor and the sleeve of the gown nurse was wearing." an incomplete date of event of (b)(6) 2018 was provided.There was no report of patient harm.The customer later reported that there was no patient harm caused by this event.

• 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: 7686345
• Report Number: 9616066-2018-00991
• Device Sequence Number: 19003777
• Product Code: FPA
• UDI-Device Identifier: 10885403240980
• UDI-Public: 10885403240980
• 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: health professional,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/18/2018

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 Model Number: 24602-B007T
• Device Catalogue Number: 24602-B007T
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 07/13/2018
• Supplement Report FDA Received Date: 07/18/2018; 08/02/2018
• 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 UNK
• Patient Age: 40 YR