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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. GEM V/NV 20DP PS CKV 3SS DEHP FREE; INTRAVASCULAR ADMINISTRATION SET
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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. GEM V/NV 20DP PS CKV 3SS DEHP FREE; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 11522558
Device Problem Free or Unrestricted Flow (2945)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/03/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.Initial reporter addr 1: (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
 
Event Description
It was reported that at least one gem v/nv 20dp ps ckv 3ss dehp free experienced air bubbles/air in line.The following information was provided by the initial reporter: material #: 11522558 batch/lot #: unknown (possible 20116067).For the alaris/bd iv set #11522558, the ball valve in the drip chamber that is supposed to prevent air in the line has sucked air several times over the past 10 days and this is the set we use for chemotherapy so it is a patient and staff safety issue.This happens every couple of years, the last time in 2019 and then previously in 2016.Unfortunately the nurses have not saved the packaging for lot numbers nor can we save the tubing as it contains chemotherapy.I know other hospitals have experienced issues in the past with this too.
 
Event Description
It was reported that at least one gem v/nv 20dp ps ckv 3ss dehp free experienced air bubbles/air in line.The following information was provided by the initial reporter: material #: 11522558 batch/lot #: unknown (possible 20116067).For the alaris/bd iv set #11522558, the ball valve in the drip chamber that is supposed to prevent air in the line has sucked air several times over the past 10 days and this is the set we use for chemotherapy so it is a patient and staff safety issue.This happens every couple of years, the last time in 2019 and then previously in 2016.Unfortunately the nurses have not saved the packaging for lot numbers nor can we save the tubing as it contains chemotherapy.I know other hospitals have experienced issues in the past with this too.
 
Manufacturer Narrative
The following fields have been updated due to corrected information: d.4.Medical device lot#: a possible lot# of 20116067 was reported but does not correlate with the catalog# for the complaint.H.6.Investigation: no product or photo was returned by the customer.The customer complaint that the ball valve in the drip chamber that is supposed to prevent air in line has sucked air several times could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed because a lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.
 
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Brand Name
GEM V/NV 20DP PS CKV 3SS DEHP FREE
Type of Device
INTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
blvd. insurgentes no. 20351
parque industrial el florido
tijuana
MDR Report Key11918017
MDR Text Key258917509
Report Number9616066-2021-51219
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
K944320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 06/15/2021
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 Other
Device Catalogue Number11522558
Device Lot NumberSEE H.10
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/03/2021
Initial Date FDA Received06/01/2021
Supplement Dates Manufacturer Received06/15/2021
Supplement Dates FDA Received07/02/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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