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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD-SOLIS AMBULATORY INFUSION PUMP; PUMP, INFUSION, PCA

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SMITHS MEDICAL ASD, INC. CADD-SOLIS AMBULATORY INFUSION PUMP; PUMP, INFUSION, PCA Back to Search Results
Model Number 2110
Device Problems Insufficient Flow or Under Infusion (2182); Communication or Transmission Problem (2896); Connection Problem (2900); Loss of Data (2903)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/01/2023
Event Type  malfunction  
Event Description
It was reported that the device did not recognize the cassette and data loss/the comm module was not communicating.It is unknown if there was patient involvement, no adverse patient effects were reported.
 
Manufacturer Narrative
B3: event date unknown.H3: device not received by manufacturer.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 information becomes available.
 
Manufacturer Narrative
No lot number was provided; therefore, a history record review could not be conducted.D4: udi and model number are unknown, d3, g1, and g2 email is: (b)(4).
 
Manufacturer Narrative
Corrected data: d4 ¿ udi.D9: date returned to mfg 12/5/2023.One device was returned for analysis.Visual inspection showed a worn downstream occlusion seal, scratched lcd lens, and a missing battery door.There was no evidence to review in the device's event history log.A functional test was performed and the reported issue was duplicated.The probable cause of the reported issue was due to the latch lock flex sensor and printed wiring assembly (pwa) board.A history review identified there was no indication that the complaint was related to the device within the review period.
 
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Brand Name
CADD-SOLIS AMBULATORY INFUSION PUMP
Type of Device
PUMP, INFUSION, PCA
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan ln n
minneapolis MN 55442
Manufacturer (Section G)
NULL
Manufacturer Contact
reed covert
6000 nathan ln n
minneapolis, MN 55442
2247062300
MDR Report Key18425966
MDR Text Key331883825
Report Number3012307300-2024-00002
Device Sequence Number1
Product Code MEA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K170982
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 08/01/2024
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 Lay User/Patient
Device Model Number2110
Device Catalogue Number21-2111-0100-51
Device Lot Number4321040
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/29/2023
Initial Date FDA Received01/02/2024
Supplement Dates Manufacturer Received01/29/2024
02/06/2024
Supplement Dates FDA Received01/31/2024
08/01/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/10/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
CADD MEDICATION CASSETTE.
Patient Age45 YR
Patient SexFemale
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