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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION ALARIS® PC UNIT; PUMP,INFUSION
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CAREFUSION ALARIS® PC UNIT; PUMP,INFUSION Back to Search Results
Model Number 8015
Device Problem Excess Flow or Over-Infusion (1311)
Patient Problems Pain (1994); Swelling (2091); No Code Available (3191)
Event Date 07/03/2019
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.Admitting diagnosis: lumbar laminectomy.Race/ethnicity: unknown per customer.
 
Event Description
It was reported the iv pump was programmed at a rate of 200ml/hr to infuse vancomycin 200ml.The infusion was started on (b)(6) 2019 at 1214 and stopped at 1238 due to patient compliant of arm swelling and pain.The infusion report shows that only a volume of 36.2ml was infused during those 24 minutes, however the iv bag was found to be empty.The event resulted to iv site infiltration that required heat and elevation.
 
Event Description
It was reported the iv pump was programmed at a rate of 200ml/hr to infuse vancomycin 200ml.The infusion was started on (b)(6) 2019 at 1214 and stopped at 1238 due to patient compliant of arm swelling and pain.The infusion report shows that only a volume of 36.2ml was infused during those 24 minutes, however the iv bag was found to be empty.The event resulted to iv site infiltration that required heat and elevation.On-site findings-during an onsite visit, no irregularities were observed during the visual inspection or on the device logs.The asm rate accuracy testing found the device within specification (2.75% error).Received a copy of a medwatch which states, "free flow/ overinfusion fda safety report id# (b) (4)".Received a copy of a medwatch which states, "suspected free flow event fda safety report id # (b)(4)".
 
Manufacturer Narrative
The suspect has changed from an instrument (device) to a disposable set.Supplemental 322170 and initial emdr 314645 were initiated for the pcu device (8015), not the set.Reference the new manufacturer report # 9616066-2019-02861 from emdr 326904.
 
Manufacturer Narrative
The customer¿s concerns for an infusion of vancomycin 200ml where the infusion report shows 36.2ml hand infused in 24 minutes, however the bag was found empty was not confirmed in the logs; however, during testing of the administration and secondary sets fluid was observed back flow into the primary administration set was observed.There were no obvious programming errors observed in the pcu event log.Timed rate accuracy testing performed on the source pump module found the device operating in specification.During testing of the administration set, back flow was observed.Back flow into the primary iv bag can give the impression that an infusion completed sooner than expected.Inspection of the pumping mechanism found no irregularities.The root cause of the cause of the customer's report could not be confirmed.
 
Event Description
It was reported the iv pump was programmed at a rate of 200ml/hr to infuse vancomycin 200ml.The infusion was started on (b)(6), 2019 at 1214 and stopped at 1238 due to patient compliant of arm swelling and pain.The infusion report shows that only a volume of 36.2ml was infused during those 24 minutes, however the iv bag was found to be empty.The patient experienced pain and swelling.The event resulted to iv site infiltration that required heat and elevation.On-site findings-during an onsite visit, no irregularities were observed during the visual inspection or on the device logs.The asm rate accuracy testing found the device within specification (2.75% error).Received a copy of a medwatch which states, "free flow/ overinfusion fda safety report id# (b) (4)".Received a copy of a medwatch which states, "suspected free flow event fda safety report id # (b)(4)".
 
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Brand Name
ALARIS® PC UNIT
Type of Device
PUMP,INFUSION
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key8828644
MDR Text Key160932292
Report Number2016493-2019-00903
Device Sequence Number1
Product Code FRN
UDI-Device Identifier10885403801518
UDI-Public10885403801518
Combination Product (y/n)N
PMA/PMN Number
K950419
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 07/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8015
Device Catalogue Number8015
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/12/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/25/2019
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received10/08/2019
10/09/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
72213N,2426-0007, TD (B)(6) 2019; 8100,SEC TUBING,PRI TUBING, TD 07/03/2019
Patient Age45 YR
Patient Weight68
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