MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD ALARIS PUMP MODULE INFUSION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 2202-0007

Device Problem Obstruction of Flow (2423)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/24/2023

Event Type  malfunction  

Manufacturer Narrative

D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported by the customer that bd alaris pump module infusion set was clogged.The following information was provided by the initial reporter with the verbatim: the nurse caring for the patient was xxx x and i spoke with her.The patient was in the pediatric intensive care unit she was unable to continue the infusion.She provided the tubing to me.He could not be primed by gravity.The lipid infusion was running continuously and did not need to be stopped for intermittent medications.She voiced her concerns that she is concerned with the occlusions and not being able to complete the infusions.Xxx also stated that she has experienced instances of failure to prime where she had to get another set multiple times before you could prime it.It typically stops at the filter and won't go through the membrane.

Manufacturer Narrative

H6: investigation summary one used sample model 2202-0007 was returned for investigation.The received set contained lipid solution which was left in the set to more closely replicate the reported event of occlusion.Prior to functional testing the set was visually examined for defects and abnormalities.No defects or abnormalities were observed.Set was attached to an iv bag filled with 85% glycerin/ 15% water solution and primed.An infusion run was performed for 20 hrs at a rate of 1 ml/hr.No occlusion was observed.The customer complaint that there was an occlusion was unable to be replicated.Recommendations to optimize performance of in-line filters for parenteral nutrition and intravenous fat emulsion infusions (ivfe)¿ for additional information regarding the use of ivfe with in-line filter administration sets.A device history record review could not be performed because a lot number was not provided by the customer.H3 other text : see h10.

Event Description

It was reported by the customer that bd alaris pump module infusion set was clogged.The following information was provided by the initial reporter with the verbatim: the nurse caring for the patient was xxx x and i spoke with her.The patient was in the pediatric intensive care unit she was unable to continue the infusion.She provided the tubing to me.He could not be primed by gravity.The lipid infusion was running continuously and did not need to be stopped for intermittent medications.She voiced her concerns that she is concerned with the occlusions and not being able to complete the infusions.Xxx also stated that she has experienced instances of failure to prime where she had to get another set multiple times before you could prime it.It typically stops at the filter and won't go through the membrane.

• Brand Name: BD ALARIS PUMP MODULE INFUSION SET
• 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
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17716393
• MDR Text Key: 323083763
• Report Number: 9616066-2023-01869
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403274039
• UDI-Public: (01)10885403274039
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2202-0007
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1