MAUDE Adverse Event Report: ST PAUL CADD; PUMP, INFUSION

Model Number 6400

Device Problem Device Alarm System (1012)

Patient Problems Itching Sensation (1943); Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Manufacturer Narrative

No further information was provided.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 that the patient had issues with an occlusion alert on the pump and was advised by the prescriber to go to the hospital.No further issues were noticed with the pump.The central catheter line was inserted at the hospital and later it was noted that the line site was red with brown drainage to the site.The patient reported having itchiness to the site and believes it is from the adhesive.Site was noted to have redness, irritation and skin breakdown from the dressing.The patient had a tear in her dressing and stated it was from scratching the site.No further information is known.No further adverse patient effects were reported.

Manufacturer Narrative

Date of event is unknown, no information has been provided to date.No product returned to verify or replicate the complaint.No photographic/diagnostic evidence of complaint provided by the customer.The most probable cause of an occlusion is a kink in tubing/disposable.No serial number was provided so a device history record (dhr) review and service history could not be performed.If the product is returned the manufacturer will re-open the complaint for further device analysis.

• Brand Name: CADD
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 16432990
• MDR Text Key: 310128681
• Report Number: 3012307300-2023-01601
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 10/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 6400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR
• Patient Sex: Female