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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. SEC SET NO PORTS W/HANGER DEHP FREE INTRAVASCULAR ADMINISTRATION SET

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. SEC SET NO PORTS W/HANGER DEHP FREE INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 11448964
Device Problems Device Contamination with Chemical or Other Material (2944); No Flow (2991)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/29/2021
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: unknown. Device manufacture date: unknown. Investigation summary: a complaint of the drip chamber breaking from the set was received from the customer. A photo was provided to aid in the investigation of this defect. In the photo, separation of the drip chamber can be seen. The customer complaint was confirmed. A device history record review could not be performed on model 11448964 because a lot number was not provided by the customer. As the sample was not returned a definitive root cause could not be established. This incident has been added to our database of reported incidents. Our business team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported that the sec set no ports w/hanger dehp free tubing broke below the drip chamber before flushing out the cytotoxic chemotherapy medicine. The following information was provided by the initial reporter: "rn was clamping roller clamp before flushing cytotoxic chemotherapy and the tubing broke right below the drip chamber. This is a safety hazard to staff and patients in the context of hazardous drug administration. ".
 
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Brand NameSEC SET NO PORTS W/HANGER DEHP FREE
Type of DeviceINTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
blvd. insurgentes no. 20351
parque industrial el florido
tijuana
Manufacturer (Section G)
SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
blvd. insurgentes no. 20351
parque industrial el florido
tijuana
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12259600
MDR Text Key264517923
Report Number9616066-2021-51676
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K790582
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number11448964
Device Catalogue Number11448964
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/05/2021
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

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