MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC® IV TRIFURCATED MONITORING KIT 60", 3 DISPOSABLE TRANSDUCERS, 3 03 ML S; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number	46115-65
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Blood Loss (2597)
Date of Event	08/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was discarded and is unavailable for investigation.
Event or Problem Description
The event involved a transpac® iv trifurcated monitoring kit 60", 3 disposable transducers, 3 03 ml squeeze flush devices, macrodrip (polemount) unbonded that the customer reported the stopcock broke off, not disconnected, from the central venous pressure (cvp) line.The event occurred in the heart and vascular intensive care unit (hvicu).The patient had blood down her side and back which was traced back to the cvp line.There was patient involvement, however no harm, no adverse event, and no delay in critical therapy.
Additional Manufacturer Narrative
H10: the reported complaint was confirmed based on the image returned with the complaint.No product was returned for investigation; however, an image was provided with the complaint that shows a pressure tubing separation between the 48" cvp line and the male luer attached to the distal stopcock.Without the return of the used sample a comprehensive evaluation cannot be completed and a probable cause cannot be determined.A lot history review was completed on lot # 3998649 and no non-conformances were noted that would have lead to the reported complaint.

• Brand Name: TRANSPAC® IV TRIFURCATED MONITORING KIT 60", 3 DISPOSABLE TRANSDUCERS, 3 03 ML S
• 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: 8977260
• Report Number: 9617594-2019-00304
• Device Sequence Number: 18916095
• Product Code: DRS
• UDI-Device Identifier: 00887709087019
• UDI-Public: (01)00887709087019(17)220301(10)3998649
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2019

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 Expiration Date: 03/01/2022
• Device Catalogue Number: 46115-65
• Device Lot Number: 3998649
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/21/2019
• Supplement Date Received by Manufacturer: 10/04/2019
• Initial Report FDA Received Date: 09/09/2019
• Supplement Report FDA Received Date: 10/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TRIPLE SET KIT, UNK MFR.