MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL LTD. GRASEBY 500 SYRINGE PUMP; INFUSION, SYRINGE PUMP

Model Number 500

Device Problem Unknown (for use when the device problem is not known) (2204)

Patient Problem Death (1802)

Event Date 03/21/2014

Event Type  Death  

Event Description

A report was received from (b)(6) indicating that the device was in use with patient when patient passed away.Police reported to (b)(6) that device over-infused when patient expired and would like the pump tested.Medication being infused at the time was 8 mmol magnesium sulfate in 100 ml of saline over period of 1 hour.No symptoms were noted and no intervention was taken prior to patient expiration.Over-infusion is unable to be confirmed as cause of patient death at this time.Further information has been requested; no further information has been received.

Manufacturer Narrative

Device evaluation: the suspect pump was received for evaluation.Visual inspection of the pump found chips and cracks in the pump's outer case; however, these chips and cracks were determined to not have any effect on the pump's performance.The pump's history was downloaded and reviewed.The review found that two infusions were programmed on (b)(6) 2014; no issues were identified.Functional testing of the pump found no issues.The pump passed all tests within specifications.Evaluation and testing of the device found it to operate as intended.

• Brand Name: GRASEBY 500 SYRINGE PUMP
• Type of Device: INFUSION, SYRINGE PUMP
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL LTD.; luton ; UK
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL LTD.; bramingham business park; enterprise way, luton, beds LU3 4BU; UK LU3 4BU
• Manufacturer Contact: pete hirte ; 1265 grey fox road; st. paul, MN 55112 ; 6516287384
• MDR Report Key: 3834401
• MDR Text Key: 20788929
• Report Number: 2183502-2014-00305
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 500
• Device Catalogue Number: 0166-0001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/23/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/15/2014
• Distributor Facility Aware Date: 03/21/2014
• Device Age: 18 YR
• Event Location: Hospital
• Date Manufacturer Received: 04/15/2014
• Date Device Manufactured: 02/01/1996
• 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
• Patient Outcome(s): Death