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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL CADD SOLIS HPCA PUMPS - 2110; PUMP, INFUSION, PCA

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ST PAUL CADD SOLIS HPCA PUMPS - 2110; PUMP, INFUSION, PCA Back to Search Results
Model Number 2110
Device Problems Volume Accuracy Problem (1675); Power Problem (3010)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
No information has been provided to date.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.
 
Event Description
It was reported that the reason for the return of the device was due to failed preventive maintenance for volume amounts and power issues.There has been no report of patient involvement or no observable clinical symptoms or a change in symptoms identified in the patient.
 
Manufacturer Narrative
Other, other text: b5: describe event or problem: updated with additional information received.H6: event problem and evaluation codes: updates are not required.H10: no sample has been received by manufacturing.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: h3: correction: device evaluated by manufacturer: should have stated device not returned to manufacturer.
 
Event Description
Additional information was received by the manufacturer on (b)(6)2022 via email and attached in the complaint object: this is during preventative maintenance, no patient interaction.
 
Manufacturer Narrative
H10: device evaluation: the device was returned for investigation.Visual inspection and functional test were performed.The customer reported problem was not related to any previous repair.The device was received in used condition.No tamper seal was on the device.No evidence of the issue was found in the event history log.The reported complaint was not verified.The investigation was unable to duplicate the customer problem, three separate delivery accuracy tests were performed.The pump was slightly over delivering but within the published specification.The power issue was not duplicated.The reported problem was caused by the expulsor; however, no problem was found for the power issue.The root cause was traced to issues from previous repairs.For corrective action it was recommend that the pumps expulsor be trimmed in order to bring the delivery into more nominal of a range.The root cause was unknown.The product is beyond a year from manufacture date and there was no indication of a manufacturing defect during the investigation, so a device history record review was not performed.Service history review identified this device has not been in for service previously.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
 
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Brand Name
CADD SOLIS HPCA PUMPS - 2110
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
minneapolis, MN 55442
MDR Report Key15455328
MDR Text Key306323285
Report Number3012307300-2022-19756
Device Sequence Number1
Product Code MEA
UDI-Device Identifier10610586038778
UDI-Public10610586038778
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130394
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 06/15/2023
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 Operator Health Professional
Device Model Number2110
Device Catalogue Number21-2111-0300-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/12/2022
Initial Date FDA Received09/20/2022
Supplement Dates Manufacturer Received10/03/2022
03/06/2023
Supplement Dates FDA Received10/19/2022
06/19/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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