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

Model Number PCA TUBING

Device Problems False Alarm (1013); Insufficient Flow or Under Infusion (2182)

Patient Problem Therapeutic Response, Decreased (2271)

Event Type  Injury  

Manufacturer Narrative

No product will be returned.The customer¿s complaint could not be confirmed because the product will not be returned for failure investigation.The root cause of this failure was not identified.However the event occurred in the pediatric cardiovascular unit, therefore it is presumed that the patient was pediatric.

Event Description

It was reported from the pediatric cardiovascular unit that there has been a recent increase with the pca syringe modules alarming for ¿syringe patient pressure¿ during midazolam, morphine and fentanyl infusions.While troubleshooting the nurses will replace the pc unit, pump modules and tubing sets with only temporary relief from the alarms.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 patients required additional pain medication boluses to reduce agitation.If was further stated by the customer it is unknown how many events have occurred, however, in quarter 1, there were 59 total alarms.In quarter 2 through (b)(6) 2020; there were 1166 alarms.All of which occurred during versed 50ml.The census/type remained relatively constant throughout the two quarters.

Manufacturer Narrative

No product will be returned per customer.The customer complaint of tubing set caused pump interaction issues could not be confirmed due to the product was not returned for failure investigation.A photo provided by the customer shows multiple 55ml syringes, each one labeled with its own event date when incident occurred.The root cause of this failure was not identified.

Event Description

It was reported from the pediatric cardiovascular unit that there has been a recent increase with the pca syringe modules alarming for ¿syringe patient pressure¿ during midazolam, morphine and fentanyl infusions.While troubleshooting the nurses will replace the pc unit, pump modules and tubing sets with only temporary relief from the alarms.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 patients required additional pain medication boluses to reduce agitation.If was further stated by the customer it is unknown how many events have occurred, however, in quarter 1, there were 59 total alarms.In quarter 2 through (b)(6) 2020; there were 1166 alarms.All of which occurred during versed 50ml.The census/type remained relatively constant throughout the two quarters.

Event Description

It was reported from the pediatric cardiovascular unit that there has been a recent increase with the pca syringe modules alarming for ¿syringe patient pressure¿ during midazolam, morphine and fentanyl infusions.While troubleshooting the nurses will replace the pc unit, pump modules and tubing sets with only temporary relief from the alarms.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 patients required additional pain medication boluses to reduce agitation.If was further stated by the customer it is unknown how many events have occurred, however, in quarter 1, there were 59 total alarms.In quarter 2 through (b)(6) 2020; there were 1166 alarms.All of which occurred during versed 50ml.The census/type remained relatively constant throughout the two quarters.

Manufacturer Narrative

Correction on follow-up(2): disregard information in h.10.The customer did not provide a photo showing multiple 55ml syringes, each one labeled with its own event date when incident occurred.The device history record for cad_pca_tube model unknown could not be conducted because the model and lot information was not provided.The root cause of pca syringe modules alarming for ¿syringe patient pressure¿ was not identified as no product was returned.

Event Description

It was reported from the pediatric cardiovascular unit that there has been a recent increase with the pca syringe modules alarming for ¿syringe patient pressure¿ during midazolam, morphine and fentanyl infusions.While troubleshooting the nurses will replace the pc unit, pump modules and tubing sets with only temporary relief from the alarms.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 patients required additional pain medication boluses to reduce agitation.If was further stated by the customer it is unknown how many events have occurred, however, in quarter 1, there were 59 total alarms.In quarter 2 through (b)(6) 2020; there were 1166 alarms.All of which occurred during versed 50ml.The census/type remained relatively constant throughout the two quarters.

• 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 Key: 10228295
• MDR Text Key: 198356410
• Report Number: 9616066-2020-02113
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PCA TUBING
• Device Catalogue Number: PCA TUBING
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: (2) ANTI-SYPHON VALVES; (3)8120,(3)8015,(3)MONOJECT SYRINGE, 60ML, TD UNK
• Patient Outcome(s): Required Intervention