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

Model Number	10800173
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The devices have been received and the evaluation is pending.A follow up report will be submitted with investigation results once the evaluation has been completed.
Event or Problem Description
It was reported that a pca tubing set that was infusing hydromorphone through the primary site and clinimix infusing through the y-site connector was found to be cracked at the hub and leaking.The clinician changed it and when priming the new tubing the new tubing was found to be leaking as well.There was no harm.
Event or Problem Description
It was reported that a pca tubing set that was infusing hydromorphone through the primary site, and clinimix infusing through the y-site connector was found to be cracked at the hub and leaking.The clinician changed it and when priming the new tubing, this tubing was found to be leaking as well.It was further confirmed during follow-up, that there was no patient harm as a result of this event.Customer advocacy received a copy of the customer's medwatch report from the fda which states, "the connecting port on line where the cinimix was entering was cracked and leaking out.This happened with 2 different lines." an incomplete date of event of xx-jun-2019 was provided.
Additional Manufacturer Narrative
The customer's report that the pca tubing was cracked at the hub and leaking was confirmed.Inspection of the as-received samples observed a crack along the side of the set's female luer lock component.No tool markings were observed around the observed damaged area.No other damages or any issues were observed.The crack was observed to be approximately opposite the injection gate on the luer component.Fluid from the attached syringe was pushed through and it was observed that the fluid streamed out from the noted damage.The root cause of the crack was identified to be a result of internal stresses created during the manufacturing process.

• 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: 8760511
• Report Number: 9616066-2019-01856
• Device Sequence Number: 19342849
• Product Code: FPA
• UDI-Device Identifier: 10885403234385
• UDI-Public: 10885403234385
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K811885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2019

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: 10800173
• Device Catalogue Number: 10800173
• Device Lot Number: 8351555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/03/2019
• Supplement Report FDA Received Date: 10/31/2019
• Patient Sequence Number: 1
• Patient Age: 17 YR
• Patient Weight: 94