MAUDE Adverse Event Report: CARDINAL HEALTH MONOJCT 20ML SYR L-LOCK; SYRINGE, PISTON

Model Number	1182000777
Medical Device Problem Codes	Compatibility Problem (2960); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported they are using the cardinal health (cah) brand syringes in the alaris infusion pump and experiencing medication delivering faster than it should.For example, if the pump is set to infuse over 13 hours, it is delivering medication in 6-7 hours as it is detecting incorrect volumes in the pumps.Example: the pump is detecting a volume of 7, but there is only a volume of 5, so it is administering faster than set as the pump believes there is more medication to deliver over the period of time.This has led to patients receiving "life sustaining" medication too quickly.The customer stated the pharmacy did their own testing using water in the cah brand 3ml, 6ml, 20ml and 35ml syringes in the alaris pump and each time the pump detected incorrect volume, stating 100% failure rate.The hospital is pulling all cah brand syringes from the floors, starting with critical areas, and will sequester product for investigation samples.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
H6 medical device problem code was updated.
Additional Manufacturer Narrative
The reported issue has been confirmed and a capa-crp-03163 has been initiated to further investigate.In addition, the reported device is part of a recall, event-2023-05729/res 93075.Please refer to the recall for additional details.

• Brand Name: MONOJCT 20ML SYR L-LOCK
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 17690247
• Report Number: 1282497-2023-10779
• Device Sequence Number: 6435229
• Product Code: FMF
• UDI-Device Identifier: 10884521010802
• UDI-Public: 10884521010802
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1182000777
• Device Catalogue Number: 1182000777
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2023
• Supplement Date Received by Manufacturer: 08/25/2023; 08/25/2023
• Initial Report FDA Received Date: 09/06/2023
• Supplement Report FDA Received Date: 09/13/2023; 02/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown