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

Device Problem Break (1069)

Patient Problem Blood Loss (2597)

Event Date 11/12/2020

Event Type  Death  

Manufacturer Narrative

The device was discarded.Without the returned device a probable cause is unable to be determined.

Event 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.

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,
• Type of Device: 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
• MDR Text Key: 220883254
• Report Number: 9617594-2020-00536
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 00840619028053
• UDI-Public: (01)00840619028053(17)230701(10)4937589
• Combination Product (y/n): N
• PMA/PMN Number: K052828
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2023
• Device Catalogue Number: 426460406
• Device Lot Number: 4937589
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death