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

Model Number 10015612

Device Problems Fluid/Blood Leak (1250); Device Operates Differently Than Expected (2913)

Patient Problems Therapeutic Response, Decreased (2271); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Cont'd from medical devices: 8015;8100;8110;2426-0500;icu medical, therapy date unk.Although requested, the affected product has not been received.A follow up report will be submitted with investigation results should the devices be received for evaluation.

Event Description

The customer reported that during a multi-module infusion, the morphine sulfate (0.01 ml/hr, via a 60 ml syringe) infusion leaked.The leak was observed between the microclave attached to the medication syringe and the syringe pump tubing.The setup, starting at the syringe module included: a 60 ml syringe connected to a microclave, then the syringe pump tubing , then a microclave, then the patient¿s small picc (thought to be 1.0 or 1.2 fr).Another medication with the same needleless connector and tubing set up (precedex, 0.37 ml/hr in a 30 ml syringe) was also attached to the picc extension tubing via another port.At the time of the event, the infant was exhibiting withdrawal symptoms, and the leak was discovered during troubleshooting of the tubing.No other effect to the patient was reported.

• Brand Name: ALARIS SYRINGE MODULE SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: ade ajibade ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 7638389
• MDR Text Key: 112420952
• Report Number: 9616066-2018-00882
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K811885
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10015612
• Device Catalogue Number: 10015612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/29/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 49 DA