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

Model Number PCA TUBE

Device Problem False Alarm (1013)

Patient Problem Inadequate Pain Relief (2388)

Event Date 07/03/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: monoject syringe 60ml; 30863; 30194 or c25006.No product will be returned per customer.The customer complaint could not be confirmed because the product was discarded and not returned for failure investigation.The root cause of this failure was not identified.The customer stated that the patient was pediatric.

Event Description

It was reported from the pediatric cardiovascular unit that the pca syringe module alarmed for ¿syringe patient pressure¿ during a midazolam infusion.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.Recently, the customer has found that this issue occurs when anti-siphon valves are not in use.It is important to note that it appears to be happening most with infusions that are running at a lower flow rate.The pediatric patient required additional pain medication bolus' to counteract the event.

• Brand Name: PCA PUMP TUBING
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: sylvia ventura ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 10550701
• MDR Text Key: 207440862
• Report Number: 9616066-2020-02777
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• 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 the Reporter a Health Professional?: Yes
• 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
• Treatment: 8120,8015,C25012, THERAPY DATE (B)(6) 2020
• Patient Outcome(s): Required Intervention