MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA CUSTOM COMBI SET

Catalog Number 03-2722-9

Device Problems Device Alarm System (1012); Misconnection (1399); Connection Problem (2900)

Patient Problems Death (1802); Blood Loss (2597)

Event Date 12/14/2013

Event Type  Death  

Event Description

The facility medwatch was received notifying the mfr of a serious adverse event.According to the vice president and general counsel for the hemodialysis provider, a pt was receiving hemodialysis in the hospital.Admission diagnosis is not known.Approx 1 hour into treatment, the venous line became disconnected from the pt's hemodialysis catheter.A sefely hemo-clip device was not used to secure the line to the catheter prior to treatment.The attending dialysis registered nurse noted a drop in the pt's blood pressure and the pt was non-responsive.The code team was summoned to the pt's room.However, the pt had a do not resuscitate order and subsequently, expired.Per the vice president and general counsel, inquiries were made into this event and it was determined a user error by registered nurse performing the hemodialysis was the cause of the line disconnecting from the pt's catheter causing extensive blood loss.Estimated blood loss is not known at this time.The sample is not available for return to the mfr.

Manufacturer Narrative

The complainant facility was unable to provide a sample for eval.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint sample.Results of mfr investigation is pending.Based on the info provided, it is unk how the device may have caused or contributed to the event.The post market clinical department is in the process of reviewing pt treatment data info regarding the reported expiration after an the venous the disconnection.A supplemental medwatch report will be submitted upon completion of the investigation.Please reference associated mdr # 2937457-2014-00131.

• Brand Name: CUSTOM COMBI SET
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; reynosa ; MX
• Manufacturer (Section G): REYNOSA PLANT; apartado postal #326; parque ind. reynosa sur, brecha e-99; reynosa, tamps CP 8 8780; MX CP 88780
• Manufacturer Contact: tanya taft ; 920 winter street; waltham, MA 02451 ; 8006621237
• MDR Report Key: 3624458
• MDR Text Key: 4132219
• Report Number: 8030665-2014-00123
• 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: Consumer,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/31/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2016
• Device Catalogue Number: 03-2722-9
• Device Lot Number: 13KR01232
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/31/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2013
• 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: FRESENIUS 2008H HEMODIALYSIS MACHINE
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 68 YR