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U.S. Department of Health and Human Services

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

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CAREFUSION SD PCA PUMP TUBING SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number PCA TUBE
Device Problem False Alarm (1013)
Patient Problem Inadequate Pain Relief (2388)
Event Date 06/04/2020
Event Type  Injury  
Manufacturer Narrative
Concomitant of 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. Patient information and relevant information were requested but not provided however 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.
 
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Brand NamePCA PUMP TUBING
Type of DeviceSET, 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 Key10550695
MDR Text Key207585288
Report Number9616066-2020-02775
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received09/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPCA TUBE
Device Catalogue NumberPCA TUBE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
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 Treatment Data
Date Received: 09/17/2020 Patient Sequence Number: 1
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