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

Model Number	2430-0500
Medical Device Problem Codes	Fluid/Blood Leak (1250); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's weight was reported as 690 grams.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.
Event or Problem Description
The customer reported that the smartsite¿ access valve closest to the patient remained engaged after removal of an iv piggy back causing tpn to flow freely from the tubing set.The nurse capped the port with a dual cap to prevent fluid from leaking from the site.The patient required a full tubing change the next morning with a new line placed within 10 hours of the event occurring.Although there was no reported harm to the patient, a sepsis workup was in progress on (b)(6) 2018 with blood cultures pending.It was later reported that the patient did not develop sepsis.
Additional Manufacturer Narrative
The customer¿s report that the smartsite valve closest to the patient remained engaged after removal of an iv piggy back was confirmed.Visual inspection of the set showed that the distal smartsite was received with the blue piston engaged, and a white cloudiness within the body of the middle smartsite.The white cloudiness is evidence of excessive use of alcohol for disinfection as it ingressed into the body of the valve.The rest of the set had traces of dried white medication on the outside.Functional and pressure testing resulted in no leaking or pump alarms.The distal smartsite remained engaged after disconnecting the lab syringe.The root cause is excessive use of alcohol for disinfection resulting in the smartsite¿s temporary inability to function properly.
Event or Problem Description
The customer reported that during infusions of tpn d 8.5 at a rate of 2.4ml/hour, il at 0.1ml/hour and a carrier fluid of ns 0.45% at 0.2ml/hour, the smartsite¿ access valve closest to the patient remained engaged after removal of an iv piggy back.This caused the tpn to flow freely from the tubing set.The nurse capped the port with a dual cap to prevent fluid from leaking from the site.The patient required a full tubing change the next morning with a new line placed within 10 hours of the event occurring.Although there was no reported harm to the patient, a sepsis workup was in progress on (b)(6) 2018 with blood cultures pending.It was later reported that the patient did not develop sepsis.
Event or Problem Description
The customer reported that during infusions of tpn d 8.5 at a rate of 2.4ml/hour, il at 0.1ml/hour and a carrier fluid of ns 0.45% at 0.2ml/hour, the smartsite¿ access valve closest to the patient remained engaged after removal of an iv piggy back.This caused the tpn to flow freely from the tubing set.The nurse capped the port with a dual cap to prevent fluid from leaking from the site.The patient required a full tubing change the next morning with a new line placed within 10 hours of the event occurring.Although there was no reported harm to the patient, a sepsis workup was in progress on 10/23/18 with blood cultures pending.It was later reported that the patient did not develop sepsis.

• 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: 8087706
• Report Number: 9616066-2018-02299
• Device Sequence Number: 251667
• Product Code: FPA
• UDI-Device Identifier: 07613203011396
• UDI-Public: 7613203011396
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 10/29/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2430-0500
• Device Catalogue Number: 2430-0500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/19/2018
• Supplement Report FDA Received Date: 11/26/2018; 12/27/2018
• 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: 8015,SEC TUBING,8100, TD (B)(6) 2018
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 1 DA
• Patient Weight: 1