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

Model Number 8110

Device Problems Disconnection (1171); Loose or Intermittent Connection (1371)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

No device will be returned per customer.The customer complaint could not be confirmed because the device was not returned for failure investigation.The root cause of this failure was not identified.

Event Description

It was reported that the one year old syringe pump modules have been disconnecting from pcu's.He noticed that the female side iui of the syringe module is larger than the pcu side creating quite a bit of looseness resulting in a disconnection of the iui.This occurred during an unspecified patient infusion where someone moved the iv pole and the syringe module disconnected from the pcu.It was stated that this continued to occur each time the iv pole was moved, so they switched out to another syringe module.The disconnection continued with the second syringe module.A new pcu and syringe module was set up using the same tubing with no further problems.

Manufacturer Narrative

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.A review of the device service history record was performed beginning from the date of manufacture to the present date (b)(6) 2019 and indicated that this device has not been previously returned for service.The photo provided by the customer shows a guide hole and just used to help align the devices when they are attached and have nothing to do with devices disconnecting.The root cause of the customer¿s report of a syringe pump module disconnecting at the female pcu iui was not identified.

Event Description

It was reported that the one year old syringe pump modules have been disconnecting from pcu's.He noticed that the female side iui of the syringe module is larger than the pcu side creating quite a bit of looseness resulting in a disconnection of the iui.This occurred during an unspecified patient infusion where someone moved the iv pole and the syringe module disconnected from the pcu.It was stated that this continued to occur each time the iv pole was moved, so they switched out to another syringe module.The disconnection continued with the second syringe module.A new pcu and syringe module was set up using the same tubing with no further problems.

• Brand Name: ALARIS SYRINGE MODULE
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8608165
• MDR Text Key: 145009984
• Report Number: 2016493-2019-00494
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10885403811012
• UDI-Public: 10885403811012
• Combination Product (y/n): N
• PMA/PMN Number: K023264
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 04/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8110
• Device Catalogue Number: 8110
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8015,SYR TUBE,8110, THERAPY DATE UNK; 8015,SYR TUBE,8110, THERAPY DATE UNK