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

Catalog Number 2203-0006

Device Problem Air/Gas in Device (4062)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 01/19/2022

Event Type  Injury  

Event Description

It was reported that bd alaris pump module set, gemini light resistant had an air in the line alarm during the use of the tubing and leaked.Medical intervention was required as a result.The following information was provided by the initial reporter: "alaris pump alarmed "air in line" - line examined found to be leaking medication over pump.Pump was administering blood pressure medication to the patient which resulted in the patient having a drop in their blood pressure.Emergency action taken, medication drawn up.".

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd alaris pump module set, gemini light resistant had an air in the line alarm during the use of the tubing and leaked.Medical intervention was required as a result.The following information was provided by the initial reporter: "alaris pump alarmed "air in line" - line examined found to be leaking medication over pump.Pump was administering blood pressure medication to the patient which resulted in the patient having a drop in their blood pressure.Emergency action taken, medication drawn up.".

Manufacturer Narrative

H.6.Investigation: one 2203-0006 product was returned for investigation without packaging, the lot number was not available to assist the investigation in this instance.The product was received connected to an unknown iv bag with residual fluid inside.A visual inspection revealed the product was separated at the silicone tubing; a closer inspection identified that the tubing was torn, with part of the tubing still connected to the upper silicone tubing connector.The details of this feedback were forwarded to the manufacturing site for investigation.They confirmed that the observed damage is consistent with the component being subjected to an external force; however a review of the manufacturing and packaging process did not identify any potential sources which could cause or contribute to damage of this nature.The lot number was not available and therefore it is not possible to perform a review of the production documentation for this particular product.

• Brand Name: BD ALARIS PUMP MODULE SET, GEMINI LIGHT RESISTANT
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13454134
• MDR Text Key: 286754732
• Report Number: 9616066-2022-00068
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2203-0006
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/21/2022
• Initial Date FDA Received: 02/04/2022
• Supplement Dates Manufacturer Received: 02/07/2022
• Supplement Dates FDA Received: 02/22/2022
• 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
• Patient Outcome(s): Required Intervention