MAUDE Adverse Event Report: SMITHS MEDICAL ASD,INC. CADD EXTENSION SETS; ACCESSORIES, PUMP, INFUSION

Model Number	SET, EXTENSION, 30", M/M, 1.1 ML, ASV 50/BX
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/15/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Information received a smiths medical cadd extension sets with volume of 240 milliliters of taxol was infusing when high pressure alarm rang all night.The pump was stopped at 4:00 am and was suppose to infuse for 27 hours.No patient injury reported.

• Brand Name: CADD EXTENSION SETS
• Common Device Name: ACCESSORIES, PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD,INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 9331635
• Report Number: 3012307300-2019-06238
• Device Sequence Number: 2616510
• Product Code: MRZ
• UDI-Device Identifier: 10610586020292
• UDI-Public: 10610586020292
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K942046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/15/2019

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/13/2022
• Device Model Number: SET, EXTENSION, 30", M/M, 1.1 ML, ASV 50/BX
• Device Catalogue Number: 21-7045-24
• Device Lot Number: 57X184
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2017
• Initial Report FDA Received Date: 11/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1