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

Model Number	10015489
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/21/2020
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
The reported feedback suggests that the line fell apart.From the reported information there are no indications of serious injury to the patient or user as a result of this incident.
Event or Problem Description
The reported feedback suggests that the line fell apart.From the reported information there are no indications of serious injury to the patient or user as a result of this incident.
Additional Manufacturer Narrative
One (b)(6) sample from lot 19076755 was received for investigation in open packaging no residual fluid was present within the sample.Additionally the customer provided a photograph of the affected sample to assist the investigation.A visual inspection of the returned sample confirmed the customer's experience as the tubing had separated from below the drip chamber.Minimal residual solvent was visible on the affected tubing joint.The details of this feedback were forwarded to the manufacturing site for investigation.In this instance it is likely that the separation occurred as a result of an insufficient amount of solvent having been applied to the affected joint during the assembly process; this is a manual process and is likely to have occurred due to human error.A review of the production records for lot 19076755 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.The quality team at the manufacturing site has been informed of this report in order to be aware of the reported feedback during future production of this product.Additionally, the solvent dispenser manufacturing protocols were updated to ensure an improved solvent distribution process.A review of the customer feedback database indicates that complaints of this nature are rare and there is currently no trend for issues of this nature against the (b)(6) product.H3 other text : see section h.10.

• 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: 9688465
• Report Number: 9616066-2020-00393
• Device Sequence Number: 14306221
• Product Code: FPA
• UDI-Device Identifier: 07613203021050
• UDI-Public: 07613203021050
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2020

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: 07/27/2022
• Device Model Number: 10015489
• Device Catalogue Number: 10015489
• Device Lot Number: 19076755
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/10/2020
• Supplement Report FDA Received Date: 04/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1