MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD SOLIS VIP PUMP; PUMP, INFUSION

Model Number 2120

Device Problem Failure to Deliver (2338)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/09/2024

Event Type  malfunction  

Manufacturer Narrative

H3: device not received by manufacturer.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported that the pump did not appear to be infusing, per reporter the medication bag looked full.Infusion was started at 1320.Pump was running, with time remaining displayed as 27 hours, 8 min.Res vol 212.40ml, rate 7.8ml/hr, total given was blank according to patient.Medication label reads: total volume 360 ml, 7.8ml/hr to be infused over 36 hours.

Manufacturer Narrative

D9: date returned to mfg.: 3/7/2024.H3 and h6.Evaluation codes: updated.One device was received for evaluation.Visual inspection found a worn dso seal, scratched lcd lens, cracked battery door, damaged battery compartment, and a loose latch lock.There was no evidence in the event history log.Functional testing was unable to verify or duplicate the under-infusion issue.The loose latch lock was verified, and the latch lock was replaced.The power failure was unable to be verified or duplicated.The service history review identified no indication that the complaint was related to a service of the device within the review period.

• Brand Name: CADD SOLIS VIP PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18889395
• MDR Text Key: 337545372
• Report Number: 3012307300-2024-01304
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 15019517126587
• UDI-Public: 15019517126587
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 2120
• Device Catalogue Number: 21-2120-0104-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2020
• 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