MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA CUSTOM COMBI SET; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Catalog Number 03-2722-9

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

Patient Problem Cardiopulmonary Arrest (1765)

Event Date 03/18/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.The post market surveillance department received medical records associated with the reported event.Both a clinical investigation and plant investigation are in process.A supplemental mdr will be submitted upon completion of these activities.

Event Description

A registered nurse (rn) from the hospital reported that a patient was found to be unresponsive with approximately one hour remaining until completion of the hemodialysis (hd) treatment.The patient, noted as being a chronic hemodialysis user, was receiving hd therapy in the intensive care unit (icu) when the patient was observed to be in cardiopulmonary arrest.The treatment was terminated, and then cardiopulmonary resuscitation (cpr) was initiated by the code team.The nurse indicated that the patient¿s catheter was able to be flushed, but the patient¿s blood was not able to be rinsed back from the extracorporeal circuit.The patient¿s estimated blood loss was approximately 300ml.Furthermore, the patient received a heparin 1000u bolus pre-treatment, and then 500u every hour while being dialyzed.Follow-up information was provided which revealed that venous pressure high alarms occurred during the treatment as a result of the patient continuously lifting the access arm above their head.However, no venous pressure high alarm was present at the time of this event.Reportedly, the patient was undergoing an abdominal ultrasound, for an unknown reason, when the stenographer observed the patient to be unresponsive.Following this event, the patient was intubated.The patient¿s current condition is not known, but the nurse was able to confirm that the patient has received follow-up hd treatments with no further issues.The patient remains hospitalized.A fresenius regional equipment specialist (res) performed an on-site evaluation of the 2008t hemodialysis machine.No problems were identified; the unit was returned to service at the user facility.The dialyzer and bloodline are available for evaluation by the manufacturer.No samples of the acid/bicarb in use during the treatment are available for analysis.

Manufacturer Narrative

Manufacturer evaluation: the reported complaint is not confirmed as the complaint device was not available for manufacturer evaluation, and the lot number of the suspect device was not provided.As such, a definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.A lot history review was performed of the products shipped to the dialysis center for the three (3) month time frame which immediately preceded the event occurrence date.No information was found and no lots were identified during this review, which sought to identify the lot numbers for all bloodline tubing sets shipped to this account within the selected time frame.As the lot number was not identified by the user facility and since no lot information was identified during the ship history, a manufacturing review was not able to be performed.Clinical investigation: the patient medical records were provided by the facility on april 1, 2016 and april 22, 2016.A clinical investigation was performed to identify a causal relationship between the hemodialysis treatment and the adverse event.The medical record revealed that the ct scan of the chest was positive for a pulmonary embolus left upper lobe pulmonary artery.Additional findings show areas of the lungs with bilateral edema and/or infiltrate.The medical record confirmed that the patient has multiple co-morbidities as well as documented noncompliance related to her hypertension and diabetes.There is no allegation that a device malfunctioned occurred.According to the hemodialysis (hd) registered nurse (rn), the machine had not alarmed when patient became unresponsive.The machine did alarm at least once during treatment for high venous pressure, which the nurse attributed to the patient continuous raising of access arm.Medical records did not contain md or rn progress notes, hd treatment orders or treatment sheets, medication administration record, or a discharge summary.Based on a review of both patient medical records and customer contact information, there is no documentation that indicates a causal relationship between the fresenius bloodline and the cardiopulmonary event.

• Brand Name: CUSTOM COMBI SET
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; mike allen #1331; parque industrial reynosa; reynosa, tamaulipas cp 88780 ; MX 88780
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa, tamaulipas cp 88780 ; MX 88780
• Manufacturer Contact: tanya taft ; 920 winter st.; waltham, MA 02451 ; 7816999000
• MDR Report Key: 5573868
• MDR Text Key: 42545033
• Report Number: 8030665-2016-00177
• 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: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 03-2722-9
• Other Device ID Number: 00840861100293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2016
• 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: FRESENIUS ACID
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 70