MAUDE Adverse Event Report: NULL CADD MS3 AMBULATORY INFUSION PUMP; PUMP, INFUSION

Model Number	21-7450-24
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	Headache (1880)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the pump alarmed an error message call for service while patient was hospitalized due to previously reported ms3 pump issue, patient is on flolan.Patient complains of migraines.
Additional Manufacturer Narrative
A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
Other, other text: no product was returned.The investigation determined the most probable cause to be a board related failure, however this cannot be confirmed as no product was returned for investigation.If the product is returned this complaint will be reopened for further investigation.No serial number was provided; therefore, a history record review could not be conducted.G2 email is: regulatory.Responses@icumed.Com.

• Brand Name: CADD MS3 AMBULATORY INFUSION PUMP
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section G): NULL
• MDR Report Key: 16784198
• Report Number: 3012307300-2023-04354
• Device Sequence Number: 17563550
• Product Code: FRN
• UDI-Device Identifier: 10610586028694
• UDI-Public: 10610586028694
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K051568
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2024

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: Other
• Device Model Number: 21-7450-24
• Device Catalogue Number: 21-7450-24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2023
• Supplement Date Received by Manufacturer: 12/21/2023
• Initial Report FDA Received Date: 04/21/2023
• Supplement Report FDA Received Date: 01/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Female