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

Model Number 8100

Device Problems Pumping Stopped (1503); Insufficient Flow or Under Infusion (2182)

Patient Problem Electrolyte Imbalance (2196)

Event Date 03/15/2021

Event Type  Injury  

Manufacturer Narrative

A follow up report will be submitted once the evaluation is completed.Diagnosis- motor vehicle accident (mva).Ethnicity,race: not provided.Evaluation pending.

Event Description

It was reported that magnesium 1g/100ml was started at 0641 but during bedside report it was noted that the device was not infusing.The intended rate of infusion was 50 ml/hour, to infuse over two hours.The nurse evaluated and reprogrammed it to the appropriate rate and it was noted the device seemed to start infusing because it had started to drip within the tubing.The nurse was called back in 0725 and the pump had stopped infusing once again.The device and infusion was removed from the patient.There were no vital sign changes as patient did not receive the medication initially.A new bag of magnesium had to be ordered for the patient which delayed his low magnesium level from being treated.Patient remained stable and was able to receive their dose of magnesium later that morning.This event happened in the surgical intensive care unit (sicu).Although requested, further information not provided.

Manufacturer Narrative

Revise manufacture date in (dhr) to 07apr2015.Revised to 'no' device history review: a review of the device history record showed the device had a manufacture date of 07apr2015.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 source pump module s/n 14361044 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 in trackwise and sap was performed for the source pump module s/n (b)(6) which did not confirm similar complaints with the same or related failure mode for this customer.

Event Description

It was reported that magnesium 1g/100ml was started at 0641 but during bedside report it was noted that the device was not infusing.The intended rate of infusion was 50 ml/hour, to infuse over two hours.The nurse evaluated and reprogrammed it to the appropriate rate and it was noted the device seemed to start infusing because it had started to drip within the tubing.The nurse was called back in 0725 and the pump had stopped infusing once again.The device and infusion was removed from the patient.There were no vital sign changes as patient did not receive the medication initially.A new bag of magnesium had to be ordered for the patient which delayed his low magnesium level from being treated.Patient remained stable and was able to receive their dose of magnesium later that morning.This event happened in the surgical intensive care unit (sicu).Although requested, further information not provided.

Event Description

It was reported that magnesium 1g/100ml was started at 0641 but during bedside report it was noted that the device was not infusing.The intended rate of infusion was 50 ml/hour, to infuse over two hours.The nurse evaluated and reprogrammed it to the appropriate rate and it was noted the device seemed to start infusing because it had started to drip within the tubing.The nurse was called back in 0725 and the pump had stopped infusing once again.The device and infusion was removed from the patient.There were no vital sign changes as patient did not receive the medication initially.A new bag of magnesium had to be ordered for the patient which delayed his low magnesium level from being treated.Patient remained stable and was able to receive their dose of magnesium later that morning.This event happened in the surgical intensive care unit (sicu).Although requested, further information not provided.

Manufacturer Narrative

The customers report that the pump stopped infusing was not identified during the log review or reproduced during testing.The review of the pcu error log showed no errors or malfunctions on the reported incident date.The customer¿s report that pitocin was dripping in the drip chamber could not be confirmed or replicated during this investigation.A review of the pcu event log around the reported event date shows the pcu was powered on on the reported event date of (b)(6) 2021 at 10:05 am.The reported source pump module s/n (b)(6) was one of two devices that were attached at the time identified as channel a; and the other device was identified as lvp s/n (b)(6) (channel b).O approximately one minute later, the source pump module's flow stop was opened for two seconds; however no infusion was programmed.The primary volume infused was listed as 0 ml.O instead, a basic infusion of an unknown drug was programmed on the other pump module at 10:09:49 am.At 10:17 am, the source pump module was removed and the concomitant pump module's channel was reassigned.The source pump module's total volume infused was listed as 0 ml.O further review of the log noted the other pump module was channeled off approximately three minutes later which also powered off the pcu and there were no further infusions noted.Inspection of the pump module found no existing malfunctions that could contribute to the reported issue.The disposable set was not returned for investigation.It is possible that a leak in the set led to the drips observed in the drip chamber.Although (3) safety clamp failures occurred during worst case testing, there is no evidence of this contributing to the reported issue.Functional testing performed on the returned administration set found the secondary iv bag back flowing into the primary iv bag, indicating a check valve failure on the primary iv set.This can be perceived as an over infusion.This is considered to be an incidental finding as the report was the infusion stopped infusing twice.Functional testing performed on the source pump module found the device delivering fluids with no irregularities.Rate accuracy testing found the device in specification.Device history review: a review of the device history record showed the device had a manufacture date of 13may2015.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 source 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 in trackwise and sap was performed for the source pump module s/n (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: 11655622
• MDR Text Key: 245099819
• Report Number: 2016493-2021-502435
• 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: health professional,other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2021
• 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: 04/05/2021
• Date Manufacturer Received: 05/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 2426-0007; 8015; SEC TUBING; 2426-0007; 8015; SEC TUBING
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Weight: 122