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Catalog Number
UNKNOWN
Device Problem
Insufficient Flow or Under Infusion (2182)
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
Event Date
01/17/2022
Event Type
malfunction
Event Description
It was reported; documenting cassette #1 used with pump #1 for under-delivery of medication.No patient injury reported.(4/12) for related complaints.
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Manufacturer
(Section G)
NULL
MDR Report Key
13471401
MDR Text Key
287791921
Report Number
3012307300-2022-02771
Device Sequence Number
1
Product Code
LHI
Combination Product (y/n)
N
Reporter Country Code
US
Number of Events Reported
1
Summary Report (Y/N)
N
Report Source
Manufacturer
Source Type
User Facility
Reporter Occupation
Other
Type of Report
Initial
Report Date
02/07/2022
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 Operator
Health Professional
Device Catalogue Number
UNKNOWN
Was Device Available for Evaluation?
No
Was the Report Sent to FDA?
No
Initial Date Manufacturer Received
01/17/2022
Initial Date FDA Received
02/07/2022
Was Device Evaluated by Manufacturer?
Device Not Returned to Manufacturer
Is the Device Single Use?
Yes
Is This a Reprocessed and Reused Single-Use Device?
No
Type of Device Usage
Initial
Patient Sequence Number
1
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