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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION ALARIS® PUMP MODULE; PUMP, INFUSION
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CAREFUSION ALARIS® PUMP MODULE; PUMP, INFUSION Back to Search Results
Model Number 8100
Device Problems Fail-Safe Problem (2936); Free or Unrestricted Flow (2945)
Patient Problem No Patient Involvement (2645)
Event Date 02/08/2020
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: 250ml baxter bag, lot: y301531, exp: sep20, ns in 0.9% sodium chloride injection; two non-bd sets.The device has been received and an evaluation is pending.A follow up report will be submitted once the evaluation is completed.All available information has been provided.
 
Event Description
It was reported that 20 grams of lipids in 100ml free flowed onto the floor in the bone marrow transplant unit.This occurred after low sorb tubing, (which had been in use for one day and has since been discarded), was removed from the pump module, and the pump module failed to engage the safety clamp.The pump module is believed to have been powered off and did not alarm, and there was no patient involvement.
 
Manufacturer Narrative
Additional information added; section; b.5.(patient information clarified/detailed).****************************************************************************************** the customer¿s complaint that the safety clamp did not engage when the door was opened resulting in free flow was not confirmed in the logs, but ti was reproduced during testing.¿ review of the pcu error log showed no errors were recorded on the reported event date ¿ review of the pcu event log showed the suspect device was programmed for 72 ml of lipids to infuse over twelve (12) hours at a rate of 6 ml/hr.The infusion completed when expected and the device was channeled off.¿ the event administration set was not returned for investigation.¿ testing showed the pumping mechanism was operating within specification.¿ testing of the device sear showed the device was not engaging the safety clamp as expected; however, the system did display ¿close door/safety clamp open¿ with audible alarm.¿ note: the dfu and on the pump module door states ¿close clamp before opening door¿.¿ inspection of the device showed the latch pivot screw backing out.¿ inspection of the suspect device found no anomalies with the pumping mechanism.¿ the device was being removed from patient use at the time of the event.The proximate cause that the safety clamp did not engage when the door was opened resulting in free flow is the result of the latch pivot screw backing out causing the sear to misalign and did not engage the administration set¿s safety clamp when the door was opened.
 
Event Description
It was reported that 20 grams of lipids in 100ml free flowed onto the floor in the bone marrow transplant unit.This occurred after low sorb tubing, (which had been in use for one day and has since been discarded), was removed from the pump module, and the pump module failed to engage the safety clamp.The pump module is believed to have been powered off and did not alarm.It was further confirmed during follow up, that there was no patient involvement associated with this event, and no delay in patient care.
 
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Brand Name
ALARIS® PUMP MODULE
Type of Device
PUMP, INFUSION
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key9802611
MDR Text Key182554163
Report Number2016493-2020-00294
Device Sequence Number1
Product Code FRN
UDI-Device Identifier10885403810015
UDI-Public10885403810015
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 02/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/06/2020
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 Manufacturer03/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
(3)PRI TUBING, 2204-0007, 8015,(3)8100, TD UNKNOWN; 8120
Patient Age2 YR
Patient Weight16
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