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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION ALARIS PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR

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CAREFUSION ALARIS PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 2260-0500
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Dyspnea (1816); Hypoxia (1918); Nausea (1970); Chest Tightness/Pressure (2463)
Event Type  Injury  
Manufacturer Narrative
Concomitant medical product: baxter non-dehp y-type catheter extension set ((b)(4)); b)(4); therapy date: unk. No product will be returned per customer. The customer complaint could not be confirmed because the product was not sequestered for failure investigation. The root cause of this failure was not identified.
 
Event Description
The customer reported that the patient experienced difficulty breathing, shortness of breath, chest tightness, oxygen saturation of 88%, and nausea during a taxol infusion at 25% of the intended rate. The patient received benadryl 50 mg iv push and/or solu cortef to treat the reported symptoms. The customer reported the primary set is primed with ns and loaded into the iv pump. Once loaded into the pump, the taxol 0. 3-1. 2 mg/ml (100-500 ml bag), is spiked and the dedicated taxol line is primed via the pump at 999 ml/hr for 20 ml because the priming volume of the set is 26 ml. Prior to the taxol infusion, the patient receives secondary infusions of dexamethasone iv 10 or 20mg (depending on the protocol), ranitidine 50mg and benadryl 50 mg. The event occurred b)(6) 2017.
 
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Brand NameALARIS PUMP MODULE ADMINISTRATION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer (Section G)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer Contact
ade ajibade
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key6415188
MDR Text Key70298622
Report Number9616066-2017-00380
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K931173
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 02/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/17/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number2260-0500
Device Catalogue Number2260-0500
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/21/2017
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 Initial

Patient Treatment Data
Date Received: 03/17/2017 Patient Sequence Number: 1
Treatment
B)(4), TD: UNK.
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