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

Model Number 2420-0007

Device Problems Excess Flow or Over-Infusion (1311); Insufficient Information (3190)

Patient Problems Overdose (1988); No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Type  malfunction  

Event Description

Customer reported a secondary of vancomycin 250 ml was programmed to infuse at 157 ml/hr; however, the 250 ml bag infused within 36 minutes.No patient harm reported.The customer declined an event log review or device evaluation by carefusion customer advocacy.Biomed evaluated the pump module and placed it back into service.

Manufacturer Narrative

No product will be returned per the customer.The customer's complaint could not be confirmed due to the product was not returned for failure investigation.The root cause of this failure was not identified.

Manufacturer Narrative

Concomitant medical products: baxter, 1000ml infusion bag 0.9% lactated ringer's injection usp, lot c970707, exp 09/2016; therapy date unk.Baxter 250ml infusion bag 0.9% sodium chloride injection usp, lot c966291, exp 07/2016, labeled as vancomycin 12.5ml nacl 0.9% sodium chloride 250ml.The customer¿s report that a secondary of vancomycin infused faster than expected was not confirmed.Inspection of the primary and secondary sets and infusion bags revealed no obvious damages or issues.Functional and pressure testing was performed; no leaks or backflow was observed.The root cause of the reported issue was not identified.

Event Description

Although the customer declined an event log review or device evaluation by carefusion customer advocacy, the customer requested evaluation of the primary and secondary sets associated with the event.

Manufacturer Narrative

(b)(4).

• 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: 4765107
• MDR Text Key: 5948194
• Report Number: 9616066-2015-00580
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/17/2015

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 Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/17/2015
• Initial Date FDA Received: 05/12/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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