MAUDE Adverse Event Report: NULL CADD LEGACY 1 PUMPS 6400; PUMP, INFUSION

Model Number 21-6400-51

Device Problem Failure to Deliver (2338)

Patient Problems Diarrhea (1811); Headache (1880)

Event Type  malfunction  

Manufacturer Narrative

Other, other text: a supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported the pump would not infuse medication.No additional information is available at this time.No missed medication reported.Side effects reported headache and diarrhea.Medical doctor aware.No patient injury reported.

Manufacturer Narrative

Other text: a1: updated; b3: unknown.No product was returned.We are unable to confirm the reported complaint.If the product is returned, the manufacturer will reopen this complaint for further investigation.The most probable cause for a pump to not deliver medication is a user error in setup, or that the tubing is clamped not allowing the medication to flow; however, this cannot be confirmed as no product was returned for investigation.The service history review identified an indication that the complaint was related to a service of the device outside of the review period.

• Brand Name: CADD LEGACY 1 PUMPS 6400
• Type of Device: PUMP, INFUSION
• Manufacturer (Section G): NULL
• MDR Report Key: 16830874
• MDR Text Key: 314160631
• Report Number: 3012307300-2023-04708
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10610586019548
• UDI-Public: 10610586019548
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 21-6400-51
• Device Catalogue Number: 21-6400-51
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female