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

Model Number	10813621
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Information (3190)
Date of Event	01/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the product be received for evaluation.Although requested, no patient information provided.
Event or Problem Description
It was reported that there was tubing separation.The event occurred in the operating room as it was being "removed." it was noted that plasma-lyte was infusing kvo at the time of event.Per the reporter, "tried to remove a piece of tape that was wrapped around the tubing and the tubing was severed by the tape." it was confirmed that the tape was not present upon opening of packaging, and was used to "secure." there was no report of patient harm.There was no harm to the user, as "the tubing was clamped proximally and distally after it separated." it was reported that this event did not cause a delay in patient care.
Additional Manufacturer Narrative
The customer¿s report that the tubing "separated" was confirmed by visual inspection to be a tear in the tubing at the inlet and outlet port of the smartsite.Although the root cause was not definitively determined, the torn tubing is similar to when tubing is pulled away from the engagement with an unknown force applied, such as when the tubing is manually pulled away from the smartsite port.Functional testing was not performed as the customer's report was confirmed upon visual inspection.During visual inspection of the partial set received, in two sections of the set it was noted that the ends of the tubing were completely torn from the inlet and outlet smartsite ports.The tubing is torn (rough and jagged).The torn tubing is similar to when tubing is pulled away from the engagement with an unknown force applied, such as when the tubing is manually pulled away from the smartsite port.The root cause of the tear ("separation") between the tubing and the smartsite port was not identified.
Event or Problem Description
It was reported that there was a tubing separation.The event occurred in the operating room as it was being "removed".It was noted that plasma-lyte was infusing kvo at the time of the event.Per the reporter; "tried to remove a piece of tape that was wrapped around the tubing and the tubing was severed by the tape".It was confirmed that the tape was not present upon opening of packaging, and was used to "secure".There was no harm to the user, as "the tubing was clamped proximally and distally after it separated".It was further confirmed during follow up that patient care was not delayed and that this event did not contribute to, or result in a serious adverse impact to patient.However; it was also noted that there was no patient involvement associated with this event.

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INFUSION
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9717601
• Report Number: 9616066-2020-00502
• Device Sequence Number: 353661
• Product Code: FPA
• UDI-Device Identifier: 10885403234514
• UDI-Public: 10885403234514
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Report Date (Section B): 01/30/2020

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: 10/03/2022
• Device Model Number: 10813621
• Device Catalogue Number: 10813621
• Device Lot Number: 19105207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/17/2020
• Supplement Report FDA Received Date: 04/24/2020
• 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 (B)(6) 2020