MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA COMBI SET 8MM PRE 2 VENOUS INJECT SITES

Catalog Number 03-2922-7

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Loss of consciousness (2418)

Event Date 08/07/2015

Event Type  Injury  

Manufacturer Narrative

This report is being submitted as part of a system level review which will include an investigation of all potential fresenius products being used at the time of the event.A supplemental report will be submitted upon completion of the investigation.

Event Description

Upon medical record review obtained for an unrelated event, it was learned the patient had an unresponsive episode during dialysis on (b)(6) 2015 and required cpr and hospitalization.Upon follow up with the patient care technician (pct) it was confirmed the morbidly obese end stage renal disease (esrd) patient with history of cardiac disease became unresponsive during hemodialysis, required cpr and was hospitalized.He returned to dialysis after the hospitalization.The pct does not have any product information at this time but stated there were no product malfunctions alleged or found.The machine was not evaluated but remains in service without issue.All disposable products were discarded.From medical records: the patient was receiving dialysis when his blood pressure dropped and therefore the patient fainted and became unresponsive for 1 minute.Cpr was performed and the patient became responsive.He denied chest pain, dizziness, headache, blurry vision, shortness of breath, neck or jaw pain.

Manufacturer Narrative

A clinical investigation reveals the following: the patient was unresponsive for one minute and required cardiopulmonary resuscitation.The patient has a history of atrial fibrillation and other cardiac issues.There was no information in the medical record that indicated a causal relationship between the fresenius hemodialysis device and concomitant products and the patient's event.The device was not returned to the manufacturer for physical evaluation.The customer was unable to provide the manufacturer with the lot number of the combiset used in the reported event.As no lot number was provided by the complainant, a record review was performed on each of the lot numbers shipped to the complainant in the three months leading up to the reported event.The batch production records for these lots were reviewed.The batch records confirmed that released product met specifications; and documented manufacturing process controls were within specification.Per the documented product investigation, there was no indication that the fresenius combiset caused, contributed to or was a factor in the reported event.

• Brand Name: COMBI SET 8MM PRE 2 VENOUS INJECT SITES
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; reynosa ; MX
• Manufacturer (Section G): REYNOSA PLANT, ERIKA DE REYNOSA, S.A. DE C.V.; mike allen 1331; parque industrial reynosa
• Manufacturer Contact: tanya taft, rn, cnor ; 920 winter street; waltham, MA 02451 ; 8006621237
• MDR Report Key: 5180263
• MDR Text Key: 29402576
• Report Number: 8030665-2015-00484
• 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: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 03-2922-7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/23/2015
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 149