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

Model Number	2420-0500
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Information (3190); No Information (3190)
Date of Event	04/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information becomes available will revise accordingly.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.
Event or Problem Description
It was reported that the syringe set cracked at the blue connection.
Additional Manufacturer Narrative
Correction on initial report: d.4, d.11, g.5, and h.6 patient code.Additional information provided: b.5, d.10, g.3, and h.6 device code.Although requested, patient information was not provided.The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.
Event or Problem Description
It was reported that a leak was discovered on the tubing while the patient was asleep.Upon further inspection, it was noted that the safety clamp was found to be broken/cracked.There was no patient impact.
Event or Problem Description
It was reported that a leak was discovered on the tubing while the patient was asleep.Upon further inspection, it was noted that the safety clamp was found to be broken/cracked.There was no patient impact.
Additional Manufacturer Narrative
The customer's report that the tubing was leaking was confirmed.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Visual inspection of the set noted a cut/slice on the tubing at 5 inches below the lower fitment outlet port.No damages to the safety clamp were observed.The slice cut was measured to be.085¿ long.Functional testing confirmed leaking from the tubing cut.The cause of the leak was due to a cut in the tubing.The root cause of the observed damage tubing was not identified.Device history record could not be performed on model 2420-0500 because the lot # for the suspect set was not provided.

• 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: 10100948
• Report Number: 9616066-2020-01682
• Device Sequence Number: 3514438
• Product Code: FPA
• UDI-Device Identifier: 10885403232602
• UDI-Public: 10885403232602
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/29/2020

1 Device was Involved in the Event

2 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: 2420-0500
• Device Catalogue Number: 2420-0500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/29/2020
• Supplement Report FDA Received Date: 07/21/2020; 08/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 0
• Concomitant Medical Products and Therapy/Usage Dates: 8015,8110, THERAPY DATE (B)(6) 2020