MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC IV MONITORING KIT WITH SAFESET RESERVOIR AND 2 BLOOD SAMPLING PORTS,; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number	426460406
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	11/12/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device was discarded.Without the returned device a probable cause is unable to be determined.
Event or Problem Description
The event involved a transpac iv monitoring kit that the customer reported the transpac broke at the connection of the safeset and the tubing near the white one way stopcock during patient use.Someone became aware of the issue since the patient bled out from a major artery.The customer was unable to quantify the blood loss.The patient was a covid positive patient.The customer stated the break happened during a code.Pressure was held at the site and immediately changed out to another set.The customer stated there were no other medical interventions required related to the tubing break.The customer reported the patient deceased on a unspecified date.The customer declined to provide additional information upon follow-up.
Additional Manufacturer Narrative
H10: the reported complaint of breakage was confirmed.No videos or reported sample was returned for evaluation.However, an image was provided showing a broken tubing.It is unknown how the tubing had broken.Without the return of the reported sample a probable cause could not be determined.

• Brand Name: TRANSPAC IV MONITORING KIT WITH SAFESET RESERVOIR AND 2 BLOOD SAMPLING PORTS,
• Common Device Name: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• MDR Report Key: 10990734
• Report Number: 9617594-2020-00536
• Device Sequence Number: 777694
• Product Code: DRS
• UDI-Device Identifier: 00840619028053
• UDI-Public: (01)00840619028053(17)230701(10)4937589
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K052828
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/01/2023
• Device Catalogue Number: 426460406
• Device Lot Number: 4937589
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/16/2020
• Supplement Date Received by Manufacturer: 12/30/2020
• Initial Report FDA Received Date: 12/11/2020
• Supplement Report FDA Received Date: 01/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death