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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION SD ALARIS PUMP MODULE; PUMP, INFUSION
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CAREFUSION SD ALARIS PUMP MODULE; PUMP, INFUSION Back to Search Results
Model Number 8100
Device Problems Imprecision (1307); Insufficient Flow or Under Infusion (2182); No Audible Prompt/Feedback (2282)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
A follow up report will be submitted once the evaluation is completed.Although requested, patient information not provided.The device has been received and an evaluation is pending.
 
Event Description
It was reported that the drug did not go in as fast as it should have and that there was a clamp that should have set off a pressure alarm and it did not.This caused a delay in the infusion.It was reported by biomed that they checked the pump pressure and it goes over 20 psi and that it does not shut off.It was noted that the pressure sensor was replaced on (b)(6) 2019 and has passed two preventive maintenance since then.No patient harm.Although requested, further information not provided.
 
Event Description
It was reported that the drug did not go in as fast as it should have and that there was a clamp that should have set off a pressure alarm and it did not.This caused a delay in the infusion.It was reported by biomed that they checked the pump pressure and it goes over 20 psi and that it does not shut off.It was noted that the pressure sensor was replaced on (b)(6) 2019 and has passed two preventive maintenance since then.No patient harm.Although requested, further information not provided.
 
Manufacturer Narrative
Sample inspection: the pump module (b)(6) was received with instrument seal intact.The right (male) iui was observed with corrosion and dry fluid residue.Internal inspection observed the logic board with a tekmos processor (u11) tk80c188eb date code 1429.Log analysis results: the last programmed infusion occurred on (b)(6) 2021 at 8:08 am the pcu in use was (b)(6).At 8:08 am the source pump module was programmed 500ml/h with a vtbi 20ml and infusion was started.At 8:10 am the pump module was paused and then was channeled off.Test results: timed rate accuracy test method observed the device delivering fluid out of specification.After asm rate calibration task was performed, the device was observed delivering fluid within specification.Functional testing and asm testing of the pump module¿s pressure sensors observed both pressure sensors to be working as expected.Further testing observed the device alarming intermittently for ¿check iv set¿ and patient side occlusion testing during pump module in ¿check iv set¿ error observed the device failing to occlude.Test methods: ¿ the pressure sensor malfunction test method (dir 10000360043) was performed.¿ timed rate accuracy test method (dir 10000360036) was performed on the returned source pump module device history review: a review of the device history record showed the device had a manufacture date of 08/19/2015.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 s/n 14458144 was performed which confirmed that this device was involved in a production failure qn (b)(4) which does not correlates to the customer reported issue.A review of the complaint history record in trackwise and sap was performed for the s/n 14458144 which did not confirm similar complaints with the same or related failure mode for this customer.The probable cause of the customers reported under infusion was due to the pump module being out specification for rate accuracy.Rate calibration was able to correct the issue of under infusion.The probable cause of the customers reported pump pressure going over 20 psi and not shutting off was attributed to a malfunctioning tekmos processor (u11) on the pump module logic board.Summarize the customers reported issue of underinfusion and pressure going over 20 psi and not alarming was replicated during testing of the pump module.¿ the last programmed infusion occurred on (b)(6) 2021 at 8:08 am the pcu in use was (b)(4)the programmed rate 500ml/h and vtbi 20ml infused for 2 minutes before it was paused and channeled off.¿ no errors or malfunctions were observed in the pump module error log.¿ timed rate accuracy test method observed the device delivering fluid slightly out of specification (-5.88%).After alaris system maintenance (asm) rate calibration task was performed, the device was observed delivering fluid within specification.¿ functional testing and asm testing of the pump module¿s pressure sensors observed both pressure sensors to be working as expected.¿ further testing observed the device alarming intermittently for ¿check iv set¿ and patient side occlusion testing during pump module in ¿check iv set¿ error observed the device failing to occlude.¿ failure investigation report (10000279806 v3) lvp logic board ¿check-iv set¿ error, noted that pump modules that contain the tekmos tk80c188eb microprocessor (u11) on the logic board may intermittently experience a check iv set alarm during startup even though no set is installed and may not detect a patient side occlusion if a set is installed before power up and the adc chip is not properly initialized during power up.¿ internal inspection observed the pump module¿s logic board with a tekmos processor (u11) (date code march 2014) tk80c188eb.¿ the last programmed infusion occurred on (b)(6) 2021 at 8:08 am the pcu in use was (b)(6) the programmed rate 500ml/h and vtbi 20ml infused for 2 minutes before it was paused and channeled off.¿ no errors or malfunctions were observed in the pump module error log.¿ the device was being used for treatment purposes.
 
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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 Key11589638
MDR Text Key242957553
Report Number2016493-2021-500032
Device Sequence Number1
Product Code FRN
Combination Product (y/n)N
PMA/PMN Number
K133532
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 03/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8100
Device Catalogue Number8100
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/18/2021
Date Manufacturer Received06/10/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
8015; PRI TUBING; 8015; PRI TUBING
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