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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 Problems Therapeutic Response, Decreased (2271); Inadequate Pain Relief (2388)
Event Date 05/18/2020
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: (2) anti-syphon valves; monoject 60ml syringe.Although requested, device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.The event was reported to have occurred in the pediatric department therefore it is presumed the patient was a pediatric patient.
 
Event Description
It was reported from the pediatric cardiovascular unit that the pca syringe module continuously alarmed for ¿syringe patient pressure¿ during midazolam 55mg/55ml (1mg/ml).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 patient required additional medication boluses in order to reduce agitation and pain.It was further stated that the device experienced approximately 11 nuisance alarms.
 
Manufacturer Narrative
No product will be returned.The customer provided a photo of a 55ml syringe with a yellow note labeled with its event date of (b)(6) 2020 when incident occurred.The root cause of this failure was not identified.Device history record could not be performed because the model and lot # for the suspect set were not provided.
 
Event Description
It was reported from the pediatric cardiovascular unit that the pca syringe module continuously alarmed for ¿syringe patient pressure¿ during midazolam 55mg/55ml (1mg/ml).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 patient required additional medication boluses in order to reduce agitation and pain.It was further stated that the device experienced approximately 11 nuisance alarms.
 
Event Description
It was reported from the pediatric cardiovascular unit that the pca syringe module continuously alarmed for ¿syringe patient pressure¿ during midazolam 55mg/55ml (1mg/ml).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 patient required additional medication boluses in order to reduce agitation and pain.It was further stated that the device experienced approximately 11 nuisance alarms.
 
Manufacturer Narrative
Correction: b.1 & h.1.Additional information provided: b.2.The customer¿s report of pca syringe module continuously alarmed for ¿syringe patient pressure¿ (occlusion) was not replicated when the non-bd (monoject) syringe was used during functional testing using customer designated settings.The non-bd syringe was visually inspected for damage.No damage or other abnormalities were observed.The suspect pca pump tubing was not received from the customer for inspection and testing.Functional testing (using non-bd syringe) observed occlusions at lower pressure, but not at the customer designated setting (medium), and no occlusions at high pressure when compared to a bd syringe.The above functional testing was repeated using a bd 60ml syringe.No occlusion alarms were noted by the device during infusion using the three occlusion pressure settings.The root cause of the syringe patient pressure (occlusion) alarms was not determined.The device history record for pca pump tubing lot unknown could not be conducted because the model and lot information was not provided.
 
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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
MDR Report Key10244558
MDR Text Key198334070
Report Number9616066-2020-02123
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Type of Report Initial,Followup,Followup
Report Date 06/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberPCA TUBE
Device Catalogue NumberPCA TUBE
Was Device Available for Evaluation? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
8120,8015, THERAPY DATE 05/18/2020
Patient Outcome(s) Other;
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