MAUDE Adverse Event Report: ST PAUL CADD HIGH VOLUME ADMINISTRATION SET; PUMP, INFUSION, PCA

Model Number	21-7057-24
Medical Device Problem Codes	Obstruction of Flow (2423); Blocked Connection (2888)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product sample, picture or video was received; therefore, visual, and functional testing could not be performed.A device history record (dhr) review could not be performed as the lot number was unknown.No root cause could be determined as the complaint could not be confirmed.No further action was required as the complaint was not confirmed.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# (b)(4).
Event or Problem Description
It was reported that during use of the device in the patient's home, there were issues when priming the administration tubing set.The pump kept giving an occlusion alarm when priming the tubing.Once the tubing set was finally filled there was no problem with the infusion.No patient injury was reported.

• Brand Name: CADD HIGH VOLUME ADMINISTRATION SET
• Common Device Name: PUMP, INFUSION, PCA
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15285662
• Report Number: 3012307300-2022-16031
• Device Sequence Number: 14026299
• Product Code: MEA
• UDI-Device Identifier: 10610586020407
• UDI-Public: 10610586020407
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K943310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/24/2022

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
• Operator of Device: Health Professional
• Device Model Number: 21-7057-24
• Device Catalogue Number: 21-7057-24
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2022
• Initial Report FDA Received Date: 08/24/2022
• 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 Sex: Unknown