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

Model Number 8100

Device Problems Excess Flow or Over-Infusion (1311); Free or Unrestricted Flow (2945)

Patient Problems Hypoglycemia (1912); Overdose (1988)

Event Date 01/26/2021

Event Type  malfunction  

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.

Event Description

It was reported that an overinfusion occurred on a patient.It is unknown if a patient was harmed.Although requested, further information was not provided.

Event Description

It was reported that during surgery, an insulin overinfusion occurred on a patient with an elevated blood sugar.The insulin infusion (concentration 1 unit/1ml) was started at 1245 pm at 4 units/hr.At approximately 1333, the clinician noticed that the 100ml bag of insulin was nearly empty, indicating the patient had received a large amount of insulin.Dextrose was given and a bag of d10 ns (10% dextrose in normal saline) was obtained from pharmacy.The patient had favorable outcomes following administration of dextrose.

Manufacturer Narrative

The customer¿s stated issue of an insulin over infusion was not confirmed through a review of the device logs or through testing.Inspection: an internal and external inspection were performed on the source device.The mechanism assembly was in good condition with no discrepancies noted.There were no observations of fluid ingress in the bezel or rear case.There was no contamination observed on the electronic or mechanical components.The male iui is a third-party part.The female iui¿s have dried fluid residue on the shroud.Log analysis results: results from a review of the pcu error log shows no malfunctions on the reported event date and time.Results from a review of the pcu event log shows the system was powered on 26jan2021 at 7:06:14 am.Approximately 20 seconds later anesthesia mode was enabled.The pump module was programmed to infuse drug id 288 (insulin) at 7:08:20 am and then paused.The pump module remained paused until 12:41:08 pm where it was selected.The dose was changed to 4 units/h and the rate was recalculated to 4 ml/h and the infusion started.At 1:28:08 pm there was an alarm for patient side occlusion and then the pump module was channeled off a few seconds later.The total calculated volume infused was 3.107 ml.Functional testing consisting of rate accuracy testing performed on the source pump module found the device operating in specification.The root cause of the customer¿s complaint was not definitively identified in this investigation.The returned pump module was thoroughly tested and inspected; no fault was found.Device history review: lvp (b)(6).A review of the device history record showed the device had a manufacture date of 11/29/2005.The review was performed from the date of manufacture to the date of product release for distribution.A review of the device history record in sap for sn: 9979303 was performed which confirmed that this device was not involved in a production failure that correlated to the customer reported issue.A review of the complaint history record was performed for the (b)(6) which did not confirm similar complaints with the same or related failure mode for this customer.

• Brand Name: ALARIS PUMP MODULE
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 11346307
• MDR Text Key: 232508359
• Report Number: 2016493-2021-26422
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10885403810015
• UDI-Public: 10885403810015
• Combination Product (y/n): N
• PMA/PMN Number: K133532
• 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: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8100
• Device Catalogue Number: 8100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2021
• Date Manufacturer Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PRI TUBING,8015, TD 01/26/2021
• Patient Outcome(s): Required Intervention