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

Model Number PRI TUBING

Device Problem Failure to Disconnect (2541)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/04/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: needleless connector, therapy date (b)(6) 2020.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.Per customer, it is their policy not to provide patient information.

Event Description

It was reported that during a routine 12-hour tubing change for propofol infusion, the nurse was unable to detach the needleless connector from the old tubing.A new needleless connector was then attached to the central line.There was no patient harm.The event occurred in critical care unit.A photo of the product was provided by the customer.

Event Description

It was reported that during a routine 12-hour tubing change for propofol infusion, the nurse was unable to detach the needleless connector from the old tubing.A new needleless connector was then attached to the central line.It was confirmed during follow up, that there was no patient harm or impact as a result of this event.The event occurred in the critical care unit.A photo of the product was provided by the customer.

Manufacturer Narrative

The customer¿s report that the nurse was unable to detach the needleless connector was not confirmed.The partial set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Visual inspection of the set noted that the bd-q-syte needless connector¿s female port was partially separated from the plastic body of the connector.Inspection of the male luer observed torque damage at the male luer¿s tip.The needless connector was easily detached from the male luer and a small patch of white cloudiness was observed on the male luer tip¿s plastic body.No other damages or anomalies were observed.Functional testing could not be performed due to the partially returned set.The set¿s male luer port was measured and found to be within iso standards.The root cause was not identified.

• 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: 9740018
• MDR Text Key: 190148583
• Report Number: 9616066-2020-00572
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PRI TUBING
• Device Catalogue Number: PRI TUBING
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTRAL LINE CATHETER, THERAPY DATE (B)(6) 2020