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

Model Number 8100

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/01/2021

Event Type  malfunction  

Manufacturer Narrative

Although requested, device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.

Event Description

It was reported that there was a patient involved underinfusion of ketamine that took place on (b)(6) 2021 at 0445.The intended programming was ketamine 2000mg/250 ml running at 2mg/kg/hr.The customer reported that the pump beeped ¿infusion complete¿ but there was still 30 ml remaining in the bag.Patient harm is unknown.Customer states the "profofol was restarted.Pt was already on precedex and ketamine but unable to reached level of sedation.".

Event Description

It was reported that there was a patient involved underinfusion of ketamine that took place on (b)(6) 2021 at 0445.The intended programming was ketamine 2000mg/250ml infusing at 2mg/kg/hr.The customer reported that the pump alarmed ¿infusion complete¿ with 30ml of medication remaining in the bag.Customer states the "profofol was restarted.Pt was already on precedex and ketamine but unable to reached level of sedation." it was reported that the patient was trached on (b)(6) and a peg tube was placed on (b)(6) and the event occurred in the critical care department.

Manufacturer Narrative

Additional information: d10, e2, g2 (report source).Investigation conclusion: the report of an underinfusion was confirmed through both functional testing and review of the pcu event log.The pcu event log shows pump module s/n (b)(6) was in use and infusing (drugid 355) at a rate of 36.4ml/hr.At 10:50 pm on (b)(6) 2021, the user changed the vtbi to 200ml and then started the infusion.The infusion ran until 4:19 am when the primary infusion completed.At 4:29 am, the device was channeled off.The volume recorded as being infused during this period was 203.21ml.A review of the device error logs found no errors during the time of the reported event.The description stated that the intended programming was 2000mg/250ml, which would be a concentration of 8mg/ml and at this concentration, the rate would have been 45.5l/hr, 9.1ml/hr more than the actual 36.4ml/hr.Functional testing performed found the pump module to be delivering fluid out of specification on the low side.The cause of the accuracy error was determined to be the result of wear over time due to a misassembled camshaft.Device inspection: pump module s/n (b)(6) was received with instrument seal missing.The right (male) iui was observed with damaged isolation ribs and corrosion.The left (female) iui was observed to be in good condition.Platen assembly, post, hinge, pins, springs, and buttons are all intact and did not interfere with the door operation.Latch sear was installed properly and did not interfere with the door operation.Dried fluid residue was observed around the pivot latch spring.The platen and ail assembly were observed with dry fluid residue.All possible replacement parts were observed to be bd parts.Internal inspection of the returned device found dried fluid residue on the rear case facing iui connectors.One of the logic boards black plastic rivet was broken.The motor strap had faint stripes.One of the rear cases bottom screw was missing a washer.Wear was observed to the upper bezel shoulder due to friction from the upper bearing due to a misaligned camshaft.The incident administration set was not returned and could not be inspected.Root cause analysis: the root cause of the reported underinfusion was identified as due to both user programming and the device requiring calibration due to a misassembled camshaft.Device history review: a review of the device history record showed the device had a manufacture date of 05apr2007.The review was performed from the date of manufacture to the date of product release for distribution.A review of the device history record for pump module s/n (b)(6) was performed which confirmed that this device was not involved in a production failure which correlates to the customer reported issue.A review of the complaint history record was performed for the pump module s/n (b)(6) which did not confirm similar complaints with the same or related failure mode for this customer.

Manufacturer Narrative

The investigation is pending.A follow up report will be submitted once the failure investigation has been completed.Patient information: the propofol was restarted.The patient was trached on (b)(6) and a peg tube was placed on (b)(6) for admitting diagnosis of: chf, resp failure, failure to wean.

Event Description

It was reported that there was a patient involved under infusion of ketamine that took place on (b)(6) 2021 at 0445.The intended programming was ketamine 2000mg/250ml infusing at 2mg/kg/hr.The customer reported that the pump alarmed ¿infusion complete¿ with 30ml of medication remaining in the bag.Customer states the "profofol was restarted.Patient was already on precedex and ketamine but unable to reached level of sedation." it was reported that the patient was trached on (b)(6) and a peg tube was placed on (b)(6) and the event occurred in the critical care department.

• Brand Name: ALARIS PUMP MODULE
• Type of Device: INFUSION PUMP
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 11320056
• MDR Text Key: 231651081
• Report Number: 2016493-2021-25582
• Device Sequence Number: 1
• Product Code: FRN
• 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,Followup
• Report Date: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• Is this an Adverse Event Report?: No
• 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: 02/15/2021
• Date Manufacturer Received: 03/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: (2)8100.; (3)PRI TUBING.; PRI TUBING,8015, TD (B)(6) 2021.; PRI TUBING,8015, TD (B)(6) 2021
• Patient Age: 27 YR
• Patient Weight: 177