MAUDE Adverse Event Report: CAREFUSION ALARIS EXTENSION SET; SET, EXTENSION, INTRAVASCULAR

Model Number	ME2064
Medical Device Problem Codes	Break (1069); No Flow (2991)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products -non-bd used microclave.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.Patient age and dob requested but not provided.
Event or Problem Description
It was reported that the nurse had to change out the newer extension set with the 0.2micron filter 3 separate times due to the device alarming "patient side occlusion".The nurse checked the patient's iv site for patency which had good blood return.The nurse eventually switched to one of the previously used extension set material numbers and added a filter to have the infusion complete without further complications.The nurse noted that the previous extension set that they used was 2ml, whereas this extension set is for only 0.6ml.It is also noted on the attached picture that the male luer appears to be broken or inappropriately separated.It is noted that the product has a spin collar male luer.
Event or Problem Description
It was reported that the nurse had to change out the newer extension set with the 0.2micron filter 3 separate times due to the device alarming "patient side occlusion".The nurse checked the patient's iv site for patency which had good blood return.The nurse eventually switched to one of the previously used extension set material numbers and added a filter to have the infusion complete without further complications.The nurse noted that the previous extension set that they used was 2ml, whereas this extension set is for only 0.6ml.It is also noted on the attached picture that the male luer appears to be broken or inappropriately separated.It is noted that the product has a spin collar male luer.
Additional Manufacturer Narrative
The customer¿s report of occlusion alarms was not confirmed.Functional testing of priming and infusion testing was successful and did not replicate any occlusions or occlusion alarms with the received set.The customer did not send in the pump module this event took place on.The customer¿s report that the male luer appears to be broken or inappropriately separated was not confirmed.The male luer was not observed to be broken or separated.The spin collar does separate from the male luer but is intended by design.No anomalies were observed with the received set during visual inspection.The root cause of the customer¿s report could not be identified because no occlusions, occlusion alarms, or difficulties priming were replicated during internal lab testing.The root cause of the customer¿s report could not be determined because no breaks or inappropriate separations were observed with the received set.

• Brand Name: ALARIS EXTENSION SET
• Common Device Name: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8787044
• Report Number: 9616066-2019-01945
• Device Sequence Number: 1690126
• Product Code: FPA
• UDI-Device Identifier: 10885403236280
• UDI-Public: 10885403236280
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2019

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: 11/30/2023
• Device Model Number: ME2064
• Device Catalogue Number: ME2064
• Device Lot Number: 18117183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/12/2019
• Supplement Report FDA Received Date: 08/20/2019
• 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: PRI TUBING,8100,8015,THERAPY DATE UNKNOWN