MAUDE Adverse Event Report: REYNOSA MANUFACTURING CUSTOM COMBI SET BLOODLINE

Catalog Number 03-2742-9

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Respiratory Failure (2484); Loss Of Pulse (2562)

Event Date 11/11/2013

Event Type  Injury  

Manufacturer Narrative

This report is being submitted as part of a system-level review.Reference mfr report #s 1713747-2014-99904, 8030665-2014-00161, 2937457-2014-00222, 3005162618-2014-00002, 1713747-2014-00060 and 1651896-2014-00001.Based on the information 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 requesting relevant pt medical records and treatment data regarding the reported event.A plant investigation is still in progress and a supplemental report will be submitted upon completion.

Event Description

The user facility reported that 2.5 hours into treatment with 1 hour to go, the pt went into respiratory arrest.The pt had complained she felt like her blood sugar was too high just prior to the event.Subsequent to the respiratory arrest, it was determined the pt had no pulse.Cpr was initiated and after one round of cpr and oxygen per ambu-bag, the pt began to breathe.She was awake and talking, complained of nausea, and vomited.An ambulance was called and upon arrival, ems started an iv.The pt was transported to the emergency and was admitted until (b)(6) 2013.She is reportedly fine now.According to the charge nurse and clinic manager, there were no issues with the dialysis; the cause for the respiratory arrest was pre-existing pulmonary issues.

• Brand Name: CUSTOM COMBI SET BLOODLINE
• Manufacturer (Section D): REYNOSA MANUFACTURING; reynosa ; MX
• Manufacturer (Section G): REYNOSA PLANT; parque ind. reynosa sur, brecha e-99; apartado postal #326; reynosa, tamps 8878 0; MX 88780
• Manufacturer Contact: tanya taft, rn ; 920 winter street; waltham, MA 02451 ; 7816999751
• MDR Report Key: 3670223
• MDR Text Key: 19796126
• Report Number: 8030665-2014-00161
• 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: Other
• Type of Report: Initial
• Report Date: 01/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 03-2742-9
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: GRANUFLO; NATURALYTE; FRESENIUS 2008K HEMODIALYSIS MACHINE; OPTIFLUX DIALYZER; SALINE
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 75