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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - SINGAPORE CLEARLINK SECONDARY MEDICATION SET SET, ADMINISTRATION, INTRAVASCULAR

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BAXTER HEALTHCARE - SINGAPORE CLEARLINK SECONDARY MEDICATION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number JC7453
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dyspnea (1816); High Blood Pressure/ Hypertension (1908); Hypoxia (1918); Tachycardia (2095); Anxiety (2328); Loss of consciousness (2418); Respiratory Failure (2484)
Event Type  Injury  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
A patient experienced acute hypoxemic respiratory failure at a clinic following the initiation of an intravenous (iv) infusion in which a clearlink secondary medication set was in use. The cause of the event was not reported. The reaction occurred upon starting an infusion of a secondary medication (unspecified) along with normal saline, 100 cc mini-bags (non-baxter). The device set-up included an infusion pump, a primary iv administration set (both non-baxter) and a baxter clearlink secondary medication set. It was reported that this was the first secondary infusion and it was unknown if the secondary set was primed prior to use. It was reported that within minutes of starting the secondary infusion, the patient experienced apprehension, difficulty breathing, an elevation of heart rate, elevated blood pressure and subsequently lost consciousness. As a result, the patient was intubated. The patient¿s condition was stabilized and the patient regained consciousness within 15-20 minutes. The patient was transferred to the intensive care unit (icu) of a hospital. The icu doctor suggested the issue could have been caused by a possible allergy to an unspecified antibiotic given to the patient. No further detail was provided regarding the patient¿s outcome from the event. No additional information is available.
 
Manufacturer Narrative
Ninety (90) companion samples were received for evaluation, 89 of lot sr17h14031 and one of lot sr17d21021. Visual inspection on all 90 samples did not identify any abnormalities that could have contributed to the reported condition. 12 random samples were functionally tested by spiking them into an in-house 1000ml solution bag containing reverse osmosis water. The samples were then primed and attached to an in-house continu-flo primary set, which was also spiked into an in-house 1000ml solution bag containing reverse osmosis water. They were then attached to the first y site. The setup was then checked for flow, leaks and air in line. All (12) samples functioned normally with no leaks, separations or air inline noted. All on/off clamps functioned normally with complete shutoff noted. (12) random samples underwent underwater leak testing. All (12) samples passed with no leaks noted. A toxicology test was also performed, which did not reveal any issues that would have caused or contributed to the reported event. A batch review was conducted for both lot sr17h14031 and lot sr17d21021 and there were no deviations found related to this reported condition during the manufacture of either lot. The reported condition was not verified. Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand NameCLEARLINK SECONDARY MEDICATION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE - SINGAPORE
singapore
Manufacturer (Section G)
BAXTER HEALTHCARE - SINGAPORE
2 woodlands industrial park d
singapore 73875 0
SN 738750
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key7393131
MDR Text Key104201177
Report Number1416980-2018-01820
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberJC7453
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/09/2018
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

Patient Treatment Data
Date Received: 04/03/2018 Patient Sequence Number: 1
Treatment
PLUM A+ PUMP (HOSPIRA); PRIMARY ADMIN SET (HOSPIRA); SALINE (HOSPIRA/ICU MEDICAL)
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