MAUDE Adverse Event Report: ST PAUL CADD-LEGACY PCA PUMP ACCESSORIES; PUMP, INFUSION, PCA

Model Number	21-2165-64
Medical Device Problem Codes	Material Too Rigid or Stiff (1544); Optical Discoloration (2999)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device had extensive discoloration of bag and stiffening of materials, which are about 2 years old.No patient injury was reported.
Additional Manufacturer Narrative
A device history record (dhr) review cannot be performed because this product is a purchased finished good and the manufacturing record was not provided by the supplier.The manufacturing records of the product in question are retained by the supplier at their manufacturing site.The returned product cannot be located and is considered to be lost.We are unable to confirm the reported complaint.Operator of device unknown.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: CADD-LEGACY PCA PUMP ACCESSORIES
• 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; southend-on-sea; minneapolis, MN 55442
• MDR Report Key: 15334161
• Report Number: 3012307300-2022-17152
• Device Sequence Number: 15072576
• Product Code: MEA
• UDI-Device Identifier: 10610586043161
• UDI-Public: 10610586043161
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K982839
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/01/2022

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: Lay User/Patient
• Device Model Number: 21-2165-64
• Device Catalogue Number: 21-2165-64
• Device Lot Number: 07202016
• 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: 05/24/2022
• Initial Report FDA Received Date: 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2016
• 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