MAUDE Adverse Event Report: CAREFUSION SD ALARIS SYRINGE MODULE; PUMP, INFUSION

Model Number 8110

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Toxemia (2207); Toxicity (2333)

Event Date 06/16/2020

Event Type  Injury  

Manufacturer Narrative

Although requested, the affected device has not been received.A follow up report will be submitted with investigation results should the device be received for evaluation.Although requested, no patient demographics were provided.

Event Description

It was reported that there was an over infusion.Iv dinutuximab 50ml was initiated at 1800, with orders to infuse over 24 hours.At 1900, a nurse double check was performed and the iv dinutuximab was infusing at it's intended rate of 2ml/hr.At 2315, the pump alarmed and the syringe was found empty.The drug ordered to infuse over 24 hours, infused in 5 hours.Per the reporter, the pump records show that the medication was infusing at it's ordered rate of 2ml/hr however the total volume infused was only 10ml.Pharmacy confirmed that the correct drug preparation was 50ml.The drug dinutuximab is not in the facility's drug library and was programmed as a basic infusion.The patient was admitted to cpicu for toxicity complications.Although requested, no additional event or patient details provided.

Event Description

It was reported that there was an over infusion.Iv dinutuximab 50ml was initiated at 1800, with orders to infuse over 24 hours.At 1900, a nurse double check was performed and the iv dinutuximab was infusing at it's intended rate of 2ml/hr.At 2315, the pump alarmed and the syringe was found empty.The drug infused in just 5 hours.The pump records show that the medication was infusing at it's ordered rate of 2ml/hr however the total volume infused was only 10ml.Pharmacy confirmed that the correct drug preparation was 50ml.The drug, dinutuximab, is not in the facility's drug library and was programmed as a basic infusion.The patient was admitted to cpicu for toxicity complications.Although requested, no additional event or patient details were provided.

Manufacturer Narrative

Additional information added to: b5.

Manufacturer Narrative

Additional information added.The reported issue that there was an over infusion of the drug dinutuximab could not be confirmed; no product or device logs were returned for investigation.The file was opened to document the issue that was reported.No further investigation of this event is possible at this time.Device history: review of the sn (b)(6) service history record showed the device had a manufacture date of 10apr2015.A review of the device service history record was performed beginning from the date of manufacture to the present date 09oct2020 and indicated that this device has not been previously returned for service.Review of the production failure record was performed beginning from the date of manufacture through present.The failure record showed no production failure records were opened for the source device.

Event Description

It was reported that there was an over infusion.Iv dinutuximab 50ml was initiated at 1800, with orders to infuse over 24 hours.At 1900, a nurse double check was performed and the iv dinutuximab was infusing at it's intended rate of 2ml/hr.At 2315, the pump alarmed and the syringe was found empty.The drug infused in just 5 hours.The pump records show that the medication was infusing at it's ordered rate of 2ml/hr, however the total volume infused was only 10ml.Pharmacy confirmed that the correct drug preparation was 50ml.The drug, dinutuximab, is not in the facility's drug library and was programmed as a basic infusion.The patient was admitted to cpicu for toxicity complications.Although requested, no additional event or patient details were provided.

Event Description

It was reported that there was an over infusion.Iv dinutuximab 50ml was initiated at 1800, with orders to infuse over 24 hours.At 1900, a nurse double check was performed and the iv dinutuximab was infusing at it's intended rate of 2ml/hr.At 2315, the pump alarmed and the syringe was found empty.The drug infused in just 5 hours.The pump records show that the medication was infusing at it's ordered rate of 2ml/hr, however the total volume infused was only 10ml.Pharmacy confirmed that the correct drug preparation was 50ml.The drug, dinutuximab, is not in the facility's drug library and was programmed as a basic infusion.The patient was admitted to cpicu for toxicity complications.Although requested, no additional event or patient details were provided.

Manufacturer Narrative

The report of an over infusion of the medication dinutximab was is believed to be the result of the misalignment in the source syringe module¿s barrel clamp sensor and the amount of volume in the 5ml syringe (9.4399ml) at the start of the infusion suggest a larger syringe (50ml) was loaded when the infusion was initiated.Inspection: the source syringe module was received in good condition; however, the internal inspection found the barrel clamp sizing sensor dislodged from the barrel sizer.The log identified an anomaly during the infusion programming.The user loads a syringe into the source device.The device detects the syringe as a bd 5ml syringe with a volume of 9.4399ml.The infusion completes with a total volume infused of 9.496 ml which is not possible from a 5 ml syringe.Testing of the source syringe module in the ¿as received¿ condition, found the device could not identify loaded syringes.Asm testing found the device failed ¿barrel accuracy¿ testing.Inspection of the barrel clamp and sizing sensor found the sensor dislodged from the barrel clamp assembly.An urgent medical device recall notice was sent to all customers on august 4th, 2020 concerning this issue.The sizer sensor and barrel clamp were removed, and the sensor was correctly aligned with the clamp assembly.Asm barrel accuracy testing was performed.The source device passed accuracy testing.A pm was performed on the source syringe module to determine if the device is operating in specification.The device passed all pm tasks.The probable cause of the reported over infusion of the medication dinutuximab is believed to be the result of the source syringe module detecting the wrong syringe.The syringe module¿s barrel clamp sensor was found to be misaligned.This caused the source device to detect a 5ml syringe with a volume of 9.4339ml instead of a 50ml syringe with the volume approximately 45ml and infuse the entire volume in 5 hours.Device history review: review of the source syringe module (b)(6) service history record showed the device had a manufacture date of (b)(6) 2015.A review of the device service history record was performed beginning from the date of manufacture to the present date (b)(6) 2021 and indicated that this device has not been previously returned for service.Review of the production failure record was performed beginning from the date of manufacture through present.The failure record showed no production failure records were opened for the source device.The review of complaint history was performed for the returned source devices (b)(6) which did not confirm similar complaints with the same or related failure mode for this customer.

• Brand Name: ALARIS SYRINGE MODULE
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10262792
• MDR Text Key: 198491332
• Report Number: 2016493-2020-01584
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• PMA/PMN Number: K950419
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8110
• Device Catalogue Number: 8110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Date Manufacturer Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: (1) 8015(1) SYR TUBING(1) SYRINGE,TD (B)(6) 2020.; (1) 8015(1) SYR TUBING(1) SYRINGE,TD (B)(6) 2020
• Patient Outcome(s): Hospitalization; Required Intervention