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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION SD ALARIS PC UNIT; PUMP, INFUSION
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CAREFUSION SD ALARIS PC UNIT; PUMP, INFUSION Back to Search Results
Model Number 8015
Device Problems Device Alarm System (1012); Pumping Stopped (1503)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Although requested, the affected device has not been received.A follow up report will be submitted with investigation results should the device be received for evaluation.Although requested, no additional patient details were provided.
 
Event Description
It was reported that there was a system error and a channel that stopped infusing.It was noted that the pump stopped mid-infusion during an administration of dobutamine and alarmed "system failure." when the pump was turned back on, the device displayed the message "not for human use." the time and date of event is unknown.Although requested, no additional event or patient details were provided.
 
Event Description
It was reported that there was a system error and a channel that stopped infusing.It was noted that the pump stopped mid-infusion during an administration of dobutamine and alarmed "system failure." when the pump was turned back on, the device displayed the message "not for human use." the time and date of event is unknown.Although requested, no additional event or patient details were provided.
 
Manufacturer Narrative
Sample inspection: external and internal inspection were performed on the customer¿s returned pcu devices.During external inspection, the pcu device (b)(6) was received with instrument seal intact.The right (male) iui was observed to be in good condition.The left (female) iui was observed to be in good condition.Overall, no obvious issues were observed.All parts inspected are manufactured by bd.During internal inspection, the pcu device was opened for internal inspection and found there were no anomalies observed.Log analysis results: the pcu device error log shows a malfunction of the system error code: 132.3000 (tamper switch safety system/stuck closed failure) on (b)(6) 2020 at 03:32:02 am.The malfunction was for the tamper switch safety system/ stuck closed failure.The pcu event logs shows there were four pumps attached to the pcu device during an infusion when a malfunction occurred.The pcu device was silenced and then powered off by confirming system off.The malfunction occurred after the panel was locked.The pcu device was powered on and found a tamper switch keypress followed by an illegal tamper switch keypress indicating the switch was stuck due to the pcu being powered into maintenance mode.The pcu was powered off.Test results: the pcu passed the asm keypad test and found all keys functioning as intended.The pcu was powered onto maintenance mode three times successfully and found the tamper switch to being functioning as intended.A pump was attached to the customer¿s returned pcu and programmed an infusion and the pcu was locked and unlocked three times successfully and found the tamper switch during an infusion to be functioning as intended.Root cause: the probable cause of the customer¿s experience with the system error and a channel that stopped infusing was due to a stuck tamper switch.The tamper switch may be manipulated to get stuck in the depressed position within the rubber boot.The customer reported complaint of experience a system error and a channel that stopped infusing was confirmed in the device logs, however the issue could not be replicated during functional testing.¿ the review of the pcu error and event logs confirmed a system error code: 132.3000 (tamper switch safety system/ stuck closed failure) on (b)(6) 2020 at 03:32.02 am.¿ the stuck tamper switch causes a malfunction that only allows a soft key press for ¿system off¿ that powered off the pcu device.When the device was powered on, it was put into maintenance mode due to the stuck tamper switch.The event log shows a tamper switch keypress and an illegal tamper switch keypress after being powered on after the malfunction.¿ the tamper switch may be manipulated to get stuck in the depressed position within the rubber boot.This could lead to a system error code: 132.3000.The system error code may cause a delay in infusion because the infusion parameters could not be edited.
 
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Brand Name
ALARIS PC UNIT
Type of Device
PUMP, INFUSION
Manufacturer (Section D)
CAREFUSION SD
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key10938585
MDR Text Key219328812
Report Number2016493-2020-45927
Device Sequence Number1
Product Code FRN
UDI-Device Identifier10885403801532
UDI-Public10885403801532
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,foreig
Type of Report Initial,Followup
Report Date 11/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2020
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 Manufacturer12/01/2020
Date Manufacturer Received04/18/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
PRI TUBING, TD UNK; PRI TUBING, TD UNK
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