MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. GRASEBY¿ 2000 SYRINGE PUMP RANGE; PUMP, INFUSION OR SYRINGE, EXTRA-LUMINAL

Catalog Number 12D1X100

Device Problem Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/06/2018

Event Type  malfunction  

Event Description

Information was received that a smiths medical graseby infusion pump had a short circuited, and the pump burnt internally.It was noted to have happened after one hour of use.

• Brand Name: GRASEBY¿ 2000 SYRINGE PUMP RANGE
• Type of Device: PUMP, INFUSION OR SYRINGE, EXTRA-LUMINAL
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 3rd ave; no. 26; hangzhou, 31001 8; CH 310018
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7660605
• MDR Text Key: 113304443
• Report Number: 3012307300-2018-02581
• Device Sequence Number: 1
• Product Code: FIH
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 12D1X100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/09/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1