MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD®-SOLIS AMBULATORY INFUSION PUMP; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-2120-0102-51

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problems Complaint, Ill-Defined (2331); Underdose (2542)

Event Date 05/02/2016

Event Type  Injury  

Manufacturer Narrative

Voluntary medwatch form #: mw5066840.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 that a cadd®-solis ambulatory infusion pump was in use with a home care patient for infusion of antibiotics (pip tazo).According to the reporter, the total volume to be infused was 590 ml.According to the reporter, near the end of scheduled infusion (pump reservoir volume listed that 7.8 ml remained), the user checked the attached iv bag and 170 ml remained in the bag.It was unclear what the impact to the patient was.See mfr: 3012307300-2017-00427.

• Brand Name: CADD®-SOLIS AMBULATORY INFUSION PUMP
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD INC.; 3350 granada avenue; oakdale MN 55128
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6339109
• MDR Text Key: 67696405
• Report Number: 3012307300-2017-00518
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-2120-0102-51
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2017
• Initial Date FDA Received: 02/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2015
• 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
• Treatment: CADD ADMINISTRATION SET (CATALOG # 21-7322-24); ICU MEDICAL ANTISIPHON VALVE B6013; ICU MEDICAL FILTER 0.2 B1371
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention