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

Model Number 2260-0500

Device Problem Insufficient Information (3190)

Patient Problems Dyspnea (1816); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: baxter non-dehp y-type catheter extension set (2n1196); therapy date unknown.No product will be returned per customer.The customer¿s complaint could not be confirmed because the product was not sequestered and will not be returned for failure investigation.The root cause of this failure was not identified.

Event Description

The customer reported that the patient experienced lower back pain (6 out of 10 on a pain scale) and respiratory distress during a taxol infusion at a 50% rate.The patient received benadryl 50 mg iv push and/or solucortef 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 26ml.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 in (b)(6) 2016.

• Brand Name: ALARIS® PUMP MODULE ADMINISTRATION SET
• Type of Device: SET, 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: stephen bilello ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 6415135
• MDR Text Key: 70301991
• Report Number: 9616066-2017-00390
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K931173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• 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 Received: 03/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2260-0500
• Device Catalogue Number: 2260-0500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2017
• 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 Sequence Number: 1
• Treatment: 8015,(2)8100,2420-0007,11448964,10013902,TD UNK
• Patient Outcome(s): Required Intervention