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

Model Number	2120-0500
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	10/16/2019
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 device be received for evaluation.There was no patient involvement.
Event or Problem Description
It was reported that the rn took the tubing out of the package to demonstrate to another rn how the set separated on a previous event, as the rn stretched the tubing the set disconnected from the silicone segment.There was no patient involvement.
Event or Problem Description
Customer advocacy received a copy of the customer's medwatch report from the fda which states, "nurse involved in previous incident in which she was sprayed with chemotherapy, was showing a colleague what happened with her event she took a new package of primary tubing from the clean supply room and opened it to demonstrate her actions again, the tubing disconnected it appears as though this tubing comes disconnected very easily.".
Event or Problem Description
It was reported that the rn took the tubing out of the package to demonstrate to another rn how the set separated on a previous event, as the rn stretched the tubing the set disconnected from the silicone segment.There was no patient involvement.Customer advocacy received a copy of the customer's medwatch report from the fda which states; "nurse involved in previous incident in which she was sprayed with chemotherapy, was showing a colleague what happened with her event.She took a new package of primary tubing from the clean supply room and opened it to demonstrate her actions.Again, the tubing disconnected it appears as though this tubing comes disconnected very easily".
Additional Manufacturer Narrative
Correction on follow-up (2) h.10: disregard statement "the cause of the leak was due to the separation.".
Event or Problem Description
It was reported that the rn took the tubing out of the package to demonstrate to another rn how the set separated on a previous event, as the rn stretched the tubing the set disconnected from the silicone segment.There was no patient involvement.Customer advocacy received a copy of the customer's medwatch report from the fda which states; "nurse involved in previous incident in which she was sprayed with chemotherapy, was showing a colleague what happened with her event.She took a new package of primary tubing from the clean supply room and opened it to demonstrate her actions.Again, the tubing disconnected it appears as though this tubing comes disconnected very easily".
Additional Manufacturer Narrative
Additional information provided: d.10.The customer¿s report that the set disconnected from the silicone segment was confirmed.The set was visually inspected for kinks, holes/tears in the tubing or damages to the components.Visual inspection of the set noted the retainer ring on the engagement of the silicone segment to the upper fitment component was not present and the lower fitment component was deformed due to one side being slightly lifted and the release lever slightly angled towards the opposite lifted side.Examination under magnification of the silicone segment end observed evidence of a retainer ring indentation which does not look to be misaligned along the tubing, indicating that it had been properly assembled onto the set.Dimensional analysis of the upper fitment measured to be within specification(s).Slight tugging of the rest of the set¿s engagements observed no separation.The cause of the leak was due to the separation.The root cause of the customer¿s report was not identified.

• 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: 9304712
• Report Number: 9616066-2019-03208
• Device Sequence Number: 1864737
• Product Code: FPA
• UDI-Device Identifier: 07613203012690
• UDI-Public: 7613203012690
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/18/2019

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 Expiration Date: 08/12/2022
• Device Model Number: 2120-0500
• Device Catalogue Number: 2120-0500
• Device Lot Number: 19085990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 11/11/2019
• Supplement Report FDA Received Date: 12/09/2019; 01/10/2020; 01/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1