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

Model Number PCA TUBE

Device Problem False Alarm (1013)

Patient Problems Therapeutic Response, Decreased (2271); Inadequate Pain Relief (2388)

Event Type  malfunction  

Manufacturer Narrative

Concomitant: (30) anti-syphon valves; (15) monoject 60ml syringes.No product will be returned per customer.The customer complaint could not be confirmed because the product was not returned for failure investigation.The root cause of this failure was not identified.

Event Description

It was reported from the pediatric cardiovascular unit that the pca syringe module continuously alarmed for ¿syringe patient pressure¿ during versed in 50 ml and 55ml volumes and midazolam infusions on a total of 17 patients.The alarm issues started when bd performed a product change to the 60ml syringe which caused the customer to change to a non-bd 60ml syringe.The cardiovascular unit pca tubing set-up includes (2) anti-siphon valves.It is important to note that it appears to be happening most with infusions that are running at a lower flow rate with the non-bd 60ml syringe in use.The patients required additional medication boluses in order to reduce agitation and pain.If was further stated that in q1, there were a total of 59 alarms.In q2 through june 9, 2020, there were 1166 documented nuisance alarms during versed infusions.For all pca narcotics infusions there were 241 nuisance alarms in q1 and 1318 nuisance alarms for q2.It is also noted that the patient census/type remained relatively constant throughout the two quarters.For the 17 patient events, each had a least one nuisance alarm in q2 during versed infusions and 10 of the patients had more than 10 nuisance alarms occur with three of the patients experiencing over 200 nuisance alarms.

• Brand Name: PCA PUMP TUBING
• 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: sylvia ventura ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 10247195
• MDR Text Key: 198333836
• Report Number: 9616066-2020-02152
• 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: company representative,other
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 06/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2020
• Is this an Adverse Event Report?: No
• 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