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

Model Number 8110

Device Problems Defective Alarm (1014); Infusion or Flow Problem (2964)

Patient Problems Extravasation (1842); Infiltration into Tissue (1931); Tissue Damage (2104)

Event Date 04/19/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: (6)syr tubing.The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.Patient information was requested but not provided, however the customer stated that the patient was an infant.

Event Description

It was reported that the nurse noted that the infant patient's arm was red with swelling during a potassium chloride infusion.The nurse stopped the multiple infusions infusing via the central line and disconnected the tubing sets to flush the central line.At that time, the nurse found that the central line was occluded and unable to be flushed and that the device had failed to alarm for occlusion.The central line was removed following the infiltration and the patient received wound care to counteract the event.

Manufacturer Narrative

Additional information provided: d.11, h.6 device code the customer¿s report that an occlusion occurred, and the device did not alarm for infiltration was not confirmed.The pcu event log was reviewed for the reported event date, however no issues were observed as expected, since the device is not designed to detect infiltration.A review of the device error logs found no errors during the time of the reported event.Functional testing of the returned syringe module found the device to be functioning within specification.The device is not designed to detect infiltrations.Device history review: review of the syringe module s/n (b)(6) service history record showed the device had a manufacture date of 28dec2019.A review of the device service history record was performed beginning from the date of manufacture to the present date 15may2020 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 root cause of the report that an occlusion occurred, and the device did not alarm for infiltration was identified as a training issue.Alaris devices are not designed to detect infiltration.The event administration set was not returned.

Event Description

It was reported that the nurse noted that the infant patient's arm was red and swollen during an infusion of potassium chloride infusion.The nurse stopped the multiple infusions through the central line and disconnected the tubing sets to flush the central line.At that time, the nurse found that the central line was occluded, unable to be flushed, and the device did not alarm for occlusion.The central line was removed and found that an infiltration had occurred due to the flow issue.The patient received wound care as a result of the event.

• Brand Name: ALARIS SYRINGE PUMP MODULE
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10075627
• MDR Text Key: 191692842
• Report Number: 2016493-2020-00819
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10885403811036
• UDI-Public: 10885403811036
• Combination Product (y/n): N
• PMA/PMN Number: K023264
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2020
• 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: 05/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: (2)8015,(6)8110,8100,PRI TUBING,TD (B)(6) 2020.; (2)SYR TUBE,8110.
• Patient Outcome(s): Required Intervention