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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. ADMINISTRATION SET; PUMP, INFUSION
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SMITHS MEDICAL ASD, INC. ADMINISTRATION SET; PUMP, INFUSION Back to Search Results
Catalog Number 21-0347-25
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 08/08/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Report source: (b)(6).
 
Event or Problem Description
Information was received indicating that a smiths medical administration set was found to have a leak when flushing the tubing during an infusion of aldurazyme.It was reported that subsequently a different set was used.No adverse patient effects were reported.
 
Additional Manufacturer Narrative
The large volume infusion pumps|graseby sets was investigated by the supplier.According to the investigation the reported allegation was not confirmed.However, supplied item fault found and the problem source of the reported problem is unknown.
 
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Brand Name
ADMINISTRATION SET
Common Device Name
PUMP, INFUSION
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key8977412
Report Number3012307300-2019-04595
Device Sequence Number2876863
Product Code FRN
UDI-Device Identifier00610586100485
UDI-Public00610586100485
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
K894360
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,user facility
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 12/23/2019
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 No Information
Device Catalogue Number21-0347-25
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/02/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/12/2019
Supplement Date Received by Manufacturer12/02/2019
Initial Report FDA Received Date09/09/2019
Supplement Report FDA Received Date12/23/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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