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

Model Number 2426-0500

Device Problem Leak/Splash (1354)

Patient Problems Emotional Changes (1831); No Consequences Or Impact To Patient (2199)

Event Date 08/14/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: curos cap; attached to one used 50mg/50ml argotroban vial, ndc: 0143-9559-01 (lot number illegible), exp date illegible; 500ml braun bag, lot: j8k206n, exp: 02/21, heparin sodium 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.The customer stated that the patient was an adult patient.

Event Description

It was reported that the nurse was priming the tubing set with normal saline when the tubing set began to leak and sprayed onto the patient prior to the initiation of the infusion nacl 0.9% 500ml to infuse at a rate of 20ml/hour.The customer further stated that although the patient experienced emotional distress there were no adverse effects caused to the adult patient from the event.

Manufacturer Narrative

The customer¿s report of a leak was confirmed.The set was visually inspected as received for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Visual inspection of the set noted a cut in the tubing 48 inches above the distal smartsite port.Closer inspection of the cut tubing under magnification observed the cut tubing to be jagged.There were no other anomalies observed.Functional testing confirmed leaking from the cut in the tubing; no other leaks were observed throughout the set.The source of the leak is due to a cut in the tubing.The root cause of the cut damage could not be determined.

Event Description

It was reported that the rn was priming the tubing set with normal saline, when the tubing set immediately began to leak and some sprayed onto the patient prior to the initiation of the infusion; nacl 0.9% 500ml to infuse at a rate of 20ml/hour.The customer further stated that although the patient experienced emotional distress there were no adverse effects caused to the adult patient as a result of this event.

• Brand Name: ALARIS® PUMP MODULE ADMINISTRATION SET
• Type of Device: SET,ADMINISTRATION,INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9100822
• MDR Text Key: 159584227
• Report Number: 9616066-2019-02613
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203020992
• UDI-Public: 7613203020992
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/26/2022
• Device Model Number: 2426-0500
• Device Catalogue Number: 2426-0500
• Device Lot Number: 19036618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CUROS CAP, TD (B)(6) 2019