MAUDE Adverse Event Report: CAREFUSION SD 8110 ALARIS SYRINGE PUMP; PUMP,INFUSION

Model Number 8110

Device Problems Break (1069); Crack (1135); Naturally Worn (2988); No Apparent Adverse Event (3189); Appropriate Term/Code Not Available (3191); Physical Resistance/Sticking (4012)

Patient Problem Premature Labor (2465)

Event Type  malfunction  

Manufacturer Narrative

This reported event and subsequent repairs were investigated through the service repair process.Failure data and parts-used information were reviewed for the sap and track wise files and found relevant to the service repair.This device was not previously returned for service.The database showed no quality notifications were opened for the device.A review of the device history record in sap for sn (b)(4) was performed from the date of the manufacture to date of the release of product, which confirmed that this device was not involved in a production failure, and product was returned for servicing which correlates to the customer reported issue.A review of the complaint history record in the trackwise was performed for the sn (b)(4) which confirmed no similar complaints with the same or related failure mode.The customer stated that there was no patient involvement.

Event Description

(b)(4).

• Brand Name: 8110 ALARIS SYRINGE PUMP
• Type of Device: PUMP,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: ramkumar venkatesan ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 11001201
• MDR Text Key: 221288032
• Report Number: 2016493-2020-68014
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8110
• Device Catalogue Number: 8110
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1