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

Model Number	21-7232-24
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
(2/2, reference (b)(6) for related complaints) (documenting cassette 1) per medwatch mw5109733: spontaneous call: spoke with patient regarding cadd legacy pump slow single beep.Pump shows no message initially but then it states no disposable clamp tubing.Issue started on day unknown 2022 and patient was able to start the backup pump without issues.Author reviewed and instructed patient to run a test using the old partially used cassette and to look at the area where the blue tab was to see if part of the cassette bladder was protruding out.Patient did confirm that this was true and using a blunt device was able to push the bladder back into the cassette.Patient replaced batteries, started pump which began infusing and continued to infuse.Author instructed patient to keep the pump running to test if it alarms again for any reason and to notify the pharmacy as needed.Patient verbalized understanding.Cassette lot number and pump serial number unknown.No further info.Pump return tracking info is not available.Photographs were not provided.This is a continuous infusion.Set flow rate and volume delivered are unk.Position of the pump when alarm occurred is unk.Did the reported product fault occur while in use with the patient? yes; did the issue cause or contribute to patient or clinical injury? no; is the actual product available for investigation? no; did we [mfr] replace the device? yes; was the patient able to successfully continue their therapy? yes; is the therapy life sustaining? yes; what was the outcome of the event? resolved.Additional information received via email from customer on (b)(6) 2022 and attached by icu medical in complaint: patient details updated in attributes.No product available for return.

• 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): 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: 14690354
• Report Number: 3012307300-2022-11885
• Device Sequence Number: 5465283
• Product Code: FPA
• UDI-Device Identifier: 10610586028410
• UDI-Public: 10610586028410
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K042172
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/14/2022

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 Model Number: 21-7232-24
• Device Catalogue Number: 21-7232-24
• 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: 06/06/2022
• Initial Report FDA Received Date: 06/14/2022
• 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 Age: 37 YR
• Patient Sex: Female