MAUDE Adverse Event Report: SMITHS MEDICAL CADD-MS 3 AMBULATORY INFUSION PUMP/DEVICE; FRN - PUMP, INFUSION

Model Number 21-7411

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

Patient Problem Death (1802)

Event Date 03/28/2014

Event Type  Death  

Event Description

A report was received stating that during use of the listed device on a pt, the pt expired.The report states that the pt was last seen alive on (b)(6) 2014 at 1:00 and was then found deceased on (b)(6) 2014 at 14:00.The pt reportedly had a history of pulmonary hypertension, raynaud's disease, and tachycardia.Further information regarding the incident has been requested.No additional information has received at this time.

Manufacturer Narrative

The device is currently being evaluated; the manufacturer will file a follow-up report detailing the results of the evaluation once it is completed.Method: the sample device was returned and is currently under investigation.

• Brand Name: CADD-MS 3 AMBULATORY INFUSION PUMP/DEVICE
• Type of Device: FRN - PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL; st. paul MN
• Manufacturer Contact: pete hirte ; 1265 grey fox road; st. paul, MN 55112 ; 6516287384
• MDR Report Key: 3802934
• MDR Text Key: 17576317
• Report Number: 2183502-2014-00265
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 21-7411
• Device Catalogue Number: 21-7411-51
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/04/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/01/2014
• Distributor Facility Aware Date: 03/28/2014
• Device Age: 54 MO
• Event Location: Other
• Date Manufacturer Received: 04/02/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death