MAUDE Adverse Event Report: CAREFUSION PCA PUMP TUBING; SET, ADMINISTRATION, INTRAVASCULAR

Model Number PCA TUBE

Device Problem False Alarm (1013)

Patient Problem Inadequate Pain Relief (2388)

Event Type  Injury  

Manufacturer Narrative

Although requested, the affected product has not been received.A follow up report will be submitted with investigation results should the product be received for evaluation.Information requested but not provided.

Event Description

It was reported from the pediatric cardiovascular unit that they have continued to experience the pca syringe modules alarming for ¿syringe patient pressure¿ during midazolam, morphine and fentanyl infusions.The alarm issues started when the customer recently changed to a non-bd 60 ml syringe, due to a recent product change to the bd 60ml syringe.The cardiovascular unit pca tubing set-up includes an anti-siphon valve to decrease air in line.The pca tubing also has an anti-siphon valve on it so there is a large amount of downstream pressure and cracking pressure that has to be resolved on 2 anti-siphon valves in order to open the valve.It is important to note that it appears to be happening most with infusions that are running at a lower flow rate.The events are impacting the patients ability to manage pain.

Event Description

It was reported from the pediatric cardiovascular unit that they have continued to experience the pca syringe modules alarming for ¿syringe patient pressure¿ during midazolam, morphine and fentanyl infusions.The alarm issues started when the customer recently changed to a non-bd 60 ml syringe, due to a recent product change to the bd 60ml syringe.The cardiovascular unit pca tubing set-up includes an anti-siphon valve to decrease air in line.The pca tubing also has an anti-siphon valve on it so there is a large amount of downstream pressure and cracking pressure that has to be resolved on 2 anti-siphon valves in order to open the valve.It is important to note that it appears to be happening most with infusions that are running at a lower flow rate.The pediatric patients are requiring additional pain medication bolus' to counteract the event.

Manufacturer Narrative

Requested but not provided, however the customer reported that the patient was a pediatric patient.Concomitant medical products: (3)monoject 60ml syringe; (6)anti-syphon valves no device will be returned per customer.The customer complaint could not be confirmed because the device was not returned for failure investigation.The root cause of this failure was not identified.

• Brand Name: PCA PUMP TUBING
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10332066
• MDR Text Key: 200609006
• Report Number: 9616066-2020-02305
• 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: other
• Type of Report: Initial,Followup
• Report Date: 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PCA TUBE
• Device Catalogue Number: PCA TUBE
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: (3) (B)(6).; 8120,8015,THERAPY DATE UNKNOWN; 8120,8015,THERAPY DATE UNKNOWN
• Patient Outcome(s): Required Intervention