MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD ADMINISTRATION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-7346-24

Device Problems Volume Accuracy Problem (1675); Failure to Infuse (2340)

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

Event Date 04/13/2022

Event Type  malfunction  

Event Description

It was reported that a full bag of medication had not infused.Cadd pump indicated 106mls to be infused for another 5 hours according to settings.However, the bag remained full.Cadd pump switched (serial number (b)(4)) and same bag and tubing connected.Patient sent home and instructed to return next morning.Patient returned wednesday april 13 with bag still full of medication.Cadd pump indicated 108mls more to be infused for another 5 hours.A new epoch bag and tubing attached and same cadd pump used.Patient sent home and instructed to return to centre at 1600hrs.Patient returned and 120mls of drug infused.Same lot number for tubing both days.No patient injury was reported.Additional information from email: on (b)(6) 2022, the patient came back a little early as it didn?t look like the bag was emptying.And again we had an almost full 500 ml bag that should be almost empty but the pump looks like it counted down; patient reported no alarms going off and the pump whirred like it was working.It turns out that it is the same pump as the first patient we had problems with (that we went on to use the ?old? tubing with and it worked fine for the 4 remaining days.We are sending the pump to biomed to have the event log downloaded (for (b)(6) 2022 as well as 2 weeks ago).We have the lot number of the tubing and also reported that the tubing had no obvious kinks in it on inspection by pharmacy during preparation.(2 more incidents of drug volume not being infused via cadd solis vip pumps for a total of 5 incidents since march 29, 2022.4 different pumps used (1 of these is a loaner from smiths medical).Serial numbers: (b)(4), (loaner).See event notes for continuation.).

Manufacturer Narrative

No product or photographic evidence were provided to aid in this investigation.The complaint report offered insufficient details to determine whether this product functioned as intended, or was used in a manner consistent with its instructions for use (ifu) or failed to meet product specifications.Lacking any additional evidence, this complaint has been closed as unconfirmed.If the product is returned, smiths medical will reopen this complaint for further investigation.A manufacturing dhr review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.

• Brand Name: CADD ADMINISTRATION SETS
• 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.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 14366379
• MDR Text Key: 291723200
• Report Number: 3012307300-2022-08606
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 15019517161953
• UDI-Public: 15019517161953
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K031361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/11/2022

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
• Device Operator: Health Professional
• Device Model Number: 21-7346-24
• Device Catalogue Number: 21-7346-24
• Device Lot Number: 4235006
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/12/2022
• Initial Date FDA Received: 05/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Race: White