MAUDE Adverse Event Report: REYNOSA MFG CUSTOM COMBI SET

Catalog Number 03-2722-9

Device Problem Detachment Of Device Component (1104)

Patient Problems Death (1802); Exsanguination (1841)

Event Date 11/30/2013

Event Type  Death  

Event Description

The user facility reported that the pt, hospitalized for necrotizing pancreatitis, was receiving a blood transfusion during dialysis.He was in the acute dialysis unit and the nurse had been sitting outside the room.The pt was being monitored frequently.Dialysis had been initiated at 3:55 pm and the transfusion was set up at 4:12 pm.The pt's son visited at 4:30 pm, then left.At 4:35 pm, the nurse went to check the pt's vitals.The nurse discovered the arterial bloodline had disconnected from the pt's dialysis catheter and there was a large amount of clotted blood in the bed.A clamp had not been used with the bloodline.The pt did not respond to resuscitation efforts and expired; he was pronounced at 4:51 pm.According to the unit director, the pt had lost about a liter of blood and the machine was not alarming.The entire arterial line was filled with air.The unit director said she tested the male luer of the bloodline after the event and it worked fine.It is unk whether there was an issue with the catheter, as it was disposed during the autopsy.The cause for the event could not be determined by the hospital but reportedly, the pt suffered from confusion and it is wondered if he may have disconnected the line himself.Reference uf report number: (b)(4).

Manufacturer Narrative

The device has not yet been received for physical eval.A plan investigation is still ongoing and a supplemental report will be submitted upon completion.The event reportedly occurred at the renal unit of (b)(6).

• Brand Name: CUSTOM COMBI SET
• Manufacturer (Section D): REYNOSA MFG; reynosa ; MX
• Manufacturer (Section G): REYNOSA PLANT; parque ind reynosa sur, brecha e-99; apartado postal #325; reynosa, tamps CP 8 8780; MX CP 88780
• Manufacturer Contact: tanya taft, rn, cnor ; 920 winter st; waltham, MA 02451 ; 7816999751
• MDR Report Key: 3606216
• MDR Text Key: 4156489
• Report Number: 8030665-2014-00006
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/04/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03-2722-9
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2013
• Was Device Evaluated by Manufacturer?: No
• 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
• Treatment: 2008K MACHINE
• Patient Outcome(s): Death
• Patient Age: 64 YR