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

Model Number 8100

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Hypoglycemia (1912); Overdose (1988); Injury (2348)

Event Date 01/07/2021

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.

Event Description

It was reported an lvp 8100 was involved in an over infusion of insulin.The order was for insulin 100 units / 100ml to infuse at 4.6 units / hour via continuous drip."at 1401, the nurse started an insulin infusion at 4.6 ml/hr.Positive patient identification (ppid) and bar code medication administration (bcma).The pump was programmed manually.The infusion was stopped at 1457.The pump recorded infusing 4.28 ml during that time.There were no other actions on the pump during that time frame.The insulin had completely infused (100ml).This resulted in a serious injury "they were able to get the patients sugar back up.".

Event Description

It was reported an lvp 8100 was involved in an over infusion of insulin.The order was for insulin 100 units/100ml to infuse at 4.6 units / hour via continuous drip."at 1401, the nurse started an insulin infusion at 4.6 ml/hr.Positive patient identification (ppid) and bar code medication administration (bcma).The insulin rate had been verified by two registered nurses.The pump was programmed manually.The infusion was stopped at 1457.The pump recorded infusing 4.28 ml during that time.There were no other actions on the pump during that time frame.The insulin had completely infused (100ml).This resulted in a serious injury "they were able to get the patients sugar back up.".

Manufacturer Narrative

The customer¿s reported complaint of an over infusion of insulin was not replicated during testing.Log analysis results: results from a review of the logs confirmed the reported insulin infusion occurring on (b)(6)2021 between 02:01 pm and 02:59 pm.Prior to the start of the infusion, the pcu was powered up at 9:45 am on that day.At the time of the reported event the system consisted of the source pump module s/n (b)(6) (channel a), pump module s/n (b)(6) (channel b), pump module s/n (b)(6) (channel c) and pump module s/n (b)(6).The profile ¿adults¿ was suspected to be in use on this date.Based on the logs, the insulin infusion was programed at 2:01 pm where the user selected a standard dose therapy type and a non-weight based dosing dose unit type.The user entered a dose of 4.6unit/h and a vtbi of 80ml.A default drug amount of (b)(4)units, diluent volume of 100mls and 4.6ml/h rate was programmed and started.The pvi was noted at 0.0ml.At 2:57 pm, the user programmed a delay until 22:22hrs and reviews the delay.The user opens the door approximately 2 minutes later and removes the device.The pvi was recorded at 4.282ml.The incident administration set was not identified with any leaks, damage or any other anomaly that may have attributed to the reported incident.Results from the administration set¿s silicone segment measurements found the set within specifications.The root cause of the customer¿s experience with an over infusion was not determined during the investigation.Device history review: a review of the device history record showed the device had a manufacture date of 05/14/2004.The review was performed beginning from the date of manufacture to the date of product release for distribution.No qn review was performed on the device since it was determined to be built prior to the implementation of sap 4.7.A review of the complaint history record was performed for the s/n (b)(6) which confirmed one similar complaint with the same or related failure mode for this customer.However, the file was closed canceled since it was a duplicate complaint.

• 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: 11254648
• MDR Text Key: 229571498
• Report Number: 2016493-2021-12343
• 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,other
• Type of Report: Initial,Followup
• Report Date: 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• 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: 02/01/2021
• Date Manufacturer Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PRI TUBING,8015, THERAPY DATE UNKNOWN
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 78