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

Model Number	21-7343-24
Medical Device Problem Code	Pumping Problem (3016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other, other text: this remediation mdr was generated under protocol b10010116, as a result of warning letter cms# 617147.No problems or issues were identified during the device history record review.No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.
Event or Problem Description
It was reported that during prefill, it was noticed that the pump supposedly required 30 milliliters (ml) to completely prefill the system, which clearly did not correlate with the volume removed from the reservoir.The actual remeasured was 4ml physician bolus and with this target of 4ml, only 2.8ml came out.This deviation seems a bit large.The customer was able to reproduce this error with the same system on another pump.With both pumps, we were then able to actually dispense 4 ml with a new system at a target of 4 ml.No patient injury was reported.

• Brand Name: CADD ADMINISTRATION SETS - FLOW STOP
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16885739
• Report Number: 3012307300-2023-05289
• Device Sequence Number: 12302771
• Product Code: FPA
• UDI-Device Identifier: 15019517191820
• UDI-Public: 15019517191820
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K040636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/08/2023

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: 21-7343-24
• Device Catalogue Number: 21-7343-24
• Device Lot Number: 4232329
• 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: 04/05/2022
• Initial Report FDA Received Date: 05/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown