MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX¿ C-FUSOR® 500ML PRESSURE INFUSOR; INFUSOR, PRESSURE, FOR I.V. BAGS

Catalog Number MX4805

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/04/2017

Event Type  malfunction  

Manufacturer Narrative

Initial reporter provided a catalog number of mx4805.Company representative provided a catalog number of mx4805 and a lot number of 3084243; however, the lot number 3084243 corresponds with the catalog number a4805.Customer has not returned the device to the manufacturer for device evaluation.If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.

Event Description

It was reported medex¿ c-fusor® 500ml pressure infusor was deflating while in use.It was noted that the device had been use for "some weeks / months" when the fault occurred.No injury was reported.

• Brand Name: MEDEX¿ C-FUSOR® 500ML PRESSURE INFUSOR
• Type of Device: INFUSOR, PRESSURE, FOR I.V. BAGS
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 6552440
• MDR Text Key: 74704816
• Report Number: 3012307300-2017-01016
• Device Sequence Number: 1
• Product Code: KZD
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/08/2017

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 Catalogue Number: MX4805
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/18/2017
• Initial Date FDA Received: 05/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1