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

Model Number	2478-0000
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected product has been received and the evaluation is pending.A follow up report will be submitted once the evaluation is completed.
Event or Problem Description
It was reported that shortly after the start of a platelet transfusion, the platelet line leaked at the entrance to the long filter chamber.The set was primed with normal saline on one spike, iv patency confirmed, and the infusion was started.The nurse then spiked the platelet bag and started to prime the tubing segment leading to the filter chamber.The leak was observed at the top of the chamber.No patient harm was reported.
Event or Problem Description
It was reported that shortly after the start of a platelet transfusion, the platelet line leaked at the entrance to the long filtered drip chamber.The set was primed with normal saline on one spike, iv patency confirmed, and the infusion was started.The nurse then spiked the platelet bag and started to prime the tubing segment leading to the filter chamber.The leak was observed at the engagement of the tubing and the top of the drip chamber.No patient harm was reported.
Additional Manufacturer Narrative
The customer's report of a leak at the top of the blood filter drip chamber was confirmed.Functional and pressure testing was performed; fluid leaked out from one of the two tubing engagements to its corresponding inlet port on the top of the blood filter drip chamber component.The pvc tubing to the observed engagement leak was slightly tugged in which the tubing was able to separate from the drip chamber component.Visual inspection of the separated tubing end observed insufficient to no areas of expected solvent.Dimensional analysis of the separated tubing measured within specification.The root cause of the customer¿s experience was due to an assembly issue of insufficient solvent being applied at the engagement of the tubing during assembly of the set.

• 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: 8043528
• Report Number: 9616066-2018-02106
• Device Sequence Number: 11121606
• Product Code: FPA
• UDI-Device Identifier: 10885403235122
• UDI-Public: 10885403235122
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K894842
• 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
• Report Date (Section B): 10/11/2018

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: 08/02/2021
• Device Model Number: 2478-0000
• Device Catalogue Number: 2478-0000
• Device Lot Number: 18085194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/06/2018
• Supplement Report FDA Received Date: 02/05/2019
• 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, TD (B)(6) 2018; NORMAL SALINE IV BAG.