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

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 Date 02/08/2018

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 and elevated blood pressure and subsequently lost consciousness.It was reported that the patient was not intubated as the patient had a drn (do not resuscitate) status.The patient¿s condition stabilized and the patient regained consciousness within 15-20 minutes.The patient was not transferred to a hospital.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.Twelve 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.Twelve (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.

• Brand Name: CLEARLINK SECONDARY MEDICATION SET
• Type of Device: SET, 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 Key: 7392795
• MDR Text Key: 104191310
• Report Number: 1416980-2018-01816
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• 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 Received: 04/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: JC7453
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/09/2018
• 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: N
• Patient Sequence Number: 1
• Treatment: PLUM A+ PUMP (HOSPIRA); PRIMARY ADMIN SET (HOSPIRA); SALINE (HOSPIRA/ICU MEDICAL)
• Patient Outcome(s): Other