MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD ALARIS¿ PCA KIT ASV MICROBORE CV; INTRAVASCULAR ADMINISTRATION SET

Model Number	10800175
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.2.Date of birth: patient¿s birthday was not provided, (b)(6) 1944 was used based on age of patient.D.4.Medical device expiration date: unknown.E.4.The initial reporter also notified the fda.Medwatch report # 2700040000-2023-8043.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.
Event or Problem Description
It was reported that during use with bd alaris¿ pca kit asv microbore cv leakage occurred.The following information was provided by the initial reporter: it was reported by the customer that when the cna went into the patient room due to a patient call light on, she volted rn "need you in 24.Iv line broke." pca tubing came apart at the y site on the hydromorphone side.Lactated ringers had been flowing through the disconnected side onto the patient.Both fluids paused.Pca tubing changed and primed through the pump.Fluids and pca reconnected to patient".Verbatim: describe the event or problem: (b)(6) 2023 at 2014 when the cna went into the patient room due to a patient call light on, she volted rn "need you in 24.Iv line broke." pca tubing came apart at the y site on the hydromorphone side.Lactated ringers had been flowing through the disconnected side onto the patient.Both fluids paused.Pca tubing changed and primed through the pump.Fluids and pca reconnected to patient.Patient changed into clean gown and new linen.What was the original intended procedure? : pca-pain control.What problem did the user have (check all that apply) :device failed (e.G.Broke, couldn't get it to work or stopped working).
Additional Manufacturer Narrative
H6: investigation summary : no product or photo was returned by the customer.The customer complaint of iv line broke could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on material 10800175 because the lot number is unknown.The root cause of this failure could not be identified without a failure investigation.H3 other text : see h10.
Event or Problem Description
It was reported that during use with bd alaris¿ pca kit asv microbore cv leakage occurred.The following information was provided by the initial reporter: it was reported by the customer that when the cna went into the patient room due to a patient call light on, she volted rn "need you in 24.Iv line broke." pca tubing came apart at the y site on the hydromorphone side.Lactated ringers had been flowing through the disconnected side onto the patient.Both fluids paused.Pca tubing changed and primed through the pump.Fluids and pca reconnected to patient".Verbatim: describe the event or problem: (b)(6) 2023 at 2014 when the cna went into the patient room due to a patient call light on, she volted rn "need you in 24.Iv line broke." pca tubing came apart at the y site on the hydromorphone side.Lactated ringers had been flowing through the disconnected side onto the patient.Both fluids paused.Pca tubing changed and primed through the pump.Fluids and pca reconnected to patient.Patient changed into clean gown and new linen.What was the original intended procedure? : pca-pain control.What problem did the user have (check all that apply) :device failed (e.G.Broke, couldn't get it to work or stopped working) ;.

• Brand Name: BD ALARIS¿ PCA KIT ASV MICROBORE CV
• Common Device Name: 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 ; 8448235433
• MDR Report Key: 17121340
• Report Number: 9616066-2023-01168
• Device Sequence Number: 7038721
• Product Code: FPA
• UDI-Device Identifier: 10885403234408
• UDI-Public: (01)10885403234408
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K811885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2023

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
• Operator of Device: Health Professional
• Device Model Number: 10800175
• Device Catalogue Number: 10800175
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2023
• Supplement Date Received by Manufacturer: 07/14/2023
• Initial Report FDA Received Date: 06/13/2023
• Supplement Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Female