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

Model Number	21-7115-24
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that, when using cassettes with pump, an under delivery issue was noted.During a visit of the sales representative, it was noted that the pump had no issue when tested with other pumps.
Additional Manufacturer Narrative
Three photos were provided by the customer which were used to conduct the device analysis since the physical units, by the time this investigation is being documented, have not been received in the tijuana site.Results: photo one shows the top of a cassette next to its original packaging and a package of aa batteries.No damage or dysfunctional conditions that could cause the reported failure are observed.Photo two shows the top of a cassette next to its original packaging and a package of aa batteries.No damage or dysfunctional conditions that could cause the reported failure are observed.Photo three shows the top of a cassette next to its original packaging and a package of aa batteries.No damage or dysfunctional conditions that could cause the reported failure are observed.The reported failure mode underdeliver cannot be confirmed based on the photos provided.Functional testing: no product has been received to conduct a functional test.Results: if the device arrives, smiths medical will reopen this complaint to include in the investigation the physical sample returned.Occurrence: per pm-1009 rev 113 cassette bag loading operation these are the current mitigations implemented in the process to prevent delivery issues: in bag loading operation ay bag folds from each side toward the center approximately 6.6 mm (1/4) to 9.5 mm (3/8) to assure the correct position of the ay bag.The pump tube is adjusted between ffp arch and hooks during assembly process following the visual aid.Detection: the following detection mitigations are placed in the manufacturing process to detect pump alarms.Cassette leak testing, install ffp clip and luer capping production performs a 100% in process inspection, to verify for occlusions, kinked tubing, components damaged, verify that the bag is properly placed and verifies that the height of the arch of the pump tube is within specification.Cassette in process testing procedure production performs an accuracy test following the pm-322 rev 106 accuracy test procedure; takes a sample of 3 parts at shift start-up, the beginning of every job; at least every 5 hours.Quality procedure for cassette regular, cassette enteral and cassette 250 ml, quality takes a sample of 15 units at an interval of 2 hours plus or minus 30 minutes, prior to placing product in bag, to verify for occlusions, kinked tubing and verify that the bag is properly placed and verifies that the height of the arch of the pump tube is within specification.No root cause could be determined since the complaint was not confirmed.No actions taken were performed since the complaint was not confirmed.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.

• Brand Name: CADD
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 16469502
• Report Number: 3012307300-2023-01931
• Device Sequence Number: 5133744
• Product Code: FPA
• UDI-Device Identifier: 10610586034503
• UDI-Public: 10610586034503
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K000942
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2023

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: Health Professional
• Device Model Number: 21-7115-24
• Device Catalogue Number: 21-7115-24
• Device Lot Number: 4295889
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2023
• Supplement Date Received by Manufacturer: 03/16/2023
• Initial Report FDA Received Date: 03/02/2023
• Supplement Report FDA Received Date: 03/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown