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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION SD ALARIS PUMP MODULE ADMINISTRATION SET; SET, ADMINISTRATION, INFUSION
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CAREFUSION SD ALARIS PUMP MODULE ADMINISTRATION SET; SET, ADMINISTRATION, INFUSION Back to Search Results
Model Number PRI TUBING
Device Problem Excess Flow or Over-Infusion (1311)
Patient Problem Death (1802)
Event Date 08/22/2019
Event Type  Death  
Manufacturer Narrative
Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the product be received for evaluation.Although requested, patient demographics (section a) requested but not provided.
 
Event Description
Received a copy of the customer's additional information letter from fda which states, ¿during the or case, bd alaris pump module alarmed "channel error" message.The infusion was running lidocane.The end user proceeded to confirm error, the channel stopped delivering medication due to error, and end-user removed the tubing set out of the module.Approximately 20-30 min later it was discovered that the entire bag of the medication was delivered to the patient.".
 
Event Description
Received a copy of the customer's medwarch report from the fda which states, ¿during the or case, bd alaris pump module alarmed "channel error" message.The infusion was running lidocane.The end user proceeded to confirm error, the channel stopped delivering medication due to error, and end-user removed the tubing set out of the module.Approximately 20-30 min later it was discovered that the entire bag of the medication was delivered to the patient." the medwatch report further stated that the error message on (b)(6) 2019 showed the message 241.4140.0, which indicates a patient side pressure sensor failure, and replacement of the patient side pressure sensor is necessary.No malfunction of the anti-free flow device/mechanism could be identified.
 
Manufacturer Narrative
Please reference (b)(4).
 
Event Description
Received a copy of the customer's medwarch report from the fda which states, ¿during the or case, bd alaris pump module alarmed "channel error" message.The infusion was running lidocane.The end user proceeded to confirm error, the channel stopped delivering medication due to error, and end-user removed the tubing set out of the module.Approximately 20-30 min later it was discovered that the entire bag of the medication was delivered to the patient." the medwatch report further stated that the error message on (b)(6) 2019 showed the message 241.4140.0, which indicates a patient side pressure sensor failure, and replacement of the patient side pressure sensor is necessary.No malfunction of the anti-free flow device/mechanism could be identified.
 
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Brand Name
ALARIS PUMP MODULE ADMINISTRATION SET
Type of Device
SET, ADMINISTRATION, INFUSION
Manufacturer (Section D)
CAREFUSION SD
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer (Section G)
CAREFUSION SD
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer Contact
john bernardo
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key9219874
MDR Text Key163192818
Report Number9616066-2019-02912
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup,Followup
Report Date 09/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberPRI TUBING
Device Catalogue NumberPRI TUBING
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/25/2022
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
8100,8015, THERAPY DATE (B)(6) 2019; 8100,8015, THERAPY DATE (B)(6) 2019
Patient Outcome(s) Death;
Patient Age82 YR
Patient SexFemale
Patient Weight78 KG
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