MAUDE Adverse Event Report: ST PAUL CADD-SOLIS AMBULATORY INFUSION PUMP; PUMP, INFUSION, PCA

Model Number 2110

Device Problem Calibration Problem (2890)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Operator of device: is unknown.No information provided to date.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.

Event Description

It was reported that the device failed calibration.No patient injury was reported.

Manufacturer Narrative

Other, other text: b5: describe event or problem: updated with additional information received.D10: device available for evaluation: updated.H3: device evaluated by manufacturer: updated.H6: event problem and evaluation codes: updated.H10: a sample has been received by manufacturing and investigation, including root cause analysis, is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available., corrected data: d4: correction: model number: 2110.

Event Description

Additional information was received by the manufacturer on 28-sept-2022 via email and attached in the complaint object: all issues with these devices were found during testing at our facility.No patient involvement was indicated to me, or our technician, at the time the pumps were received at our facility for repair and recertification.

Manufacturer Narrative

Other, other text: h6: event problem and evaluation codes: updated.H3: device evaluated by manufacturer: updated.H10: device evaluation: the device was returned for investigation.Visual inspection and functional tests were performed.The customer reported problem was not related to any previous repair.Visual inspection of the device found tamper seal missing.There was no evidence of the error found in the event history log.The customer reported problem failed calibration was verified.Performing the functional test, the downstream sensor was found stuck in the manufacturing utility mode and was unable to calibrate.The inoperable downstream occlusion sensor was the cause of the reported problem.It was recommended replacing the downstream occlusion sensor as corrective action.The root cause of the reported problem was unknown.Review the device history record for job 4233214.There was an issue with the downstream occlusion with the downstream occlusion flex not being plugged in which should not have resulted in this complaint and there was no indication of a manufacturing defect during the investigation.Service history review identified this device has not been in for service previously.

• Brand Name: CADD-SOLIS AMBULATORY INFUSION PUMP
• Type of Device: PUMP, INFUSION, PCA
• 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; 11130 strang line road; minneapolis, MN 55442
• MDR Report Key: 15463725
• MDR Text Key: 306205613
• Report Number: 3012307300-2022-20079
• Device Sequence Number: 1
• Product Code: MEA
• UDI-Device Identifier: 15019517154290
• UDI-Public: 15019517154290
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/13/2022

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
• Device Model Number: 2110
• Device Catalogue Number: 21-2111-0402-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/15/2022
• Initial Date FDA Received: 09/22/2022
• Supplement Dates Manufacturer Received: 10/05/2022; 12/06/2022
• Supplement Dates FDA Received: 10/18/2022; 12/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1