MAUDE Adverse Event Report: CONCORD MANUFACTURING CRIT-LINE III BLOOD CHAMBER II; ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS

Catalog Number 191058

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in progress.A supplemental medwatch will be submitted at the completion of these activities.Clinical investigation: a temporal association with the crit-line iii blood chamber and the reported hypotension event exists.However, based on the lack of available information potential causality cannot be established.The patient was admitted to the hospital with septic shock, colon cancer, and other comorbidities (not reported) and a reported drop in blood pressure (bp) occurred during the hemodialysis (hd) treatment.The hospital course is unknown.Additional information related to the patient's history, comorbidities, medical records and hospitalization is needed to determine potential causality.Although requested, this information has not been received.

Event Description

A facility clinic manager reported a suspected reaction to the crit-line iii blood chamber.The complainant reported that the patient was admitted to the hospital on (b)(6) 2017 with an admission diagnosis of septic shock, colon cancer and other unspecified comorbidities.The patient was initially started on continuous renal replacement therapy (crrt).However, once stable, the patient started hemodialysis (hd) therapy on a trial basis.This event represents the reported occurrence of hypotension that was experienced by the patient while undergoing the hd treatment.The event date is not known.Within the first 30 minutes of the hd treatment being initiated, the patient experienced a drop in blood pressure (no reading provided).The patient was treated with fluid replacement and albumin infusion without resolution of the low blood pressure.According to the nurse, the patient had suspected reaction to an ace inhibitor medication and it was discontinued.Reportedly, as a result of this intervention, the blood pressure did not drop as much.The patient has been returned to crrt.Follow-up was provided which revealed that the user facility only uses a fresenius crit-line iii blood chamber.The hd machine, dialyzer, bloodline, acid concentrate, and bicarb concentrate were another manufacturer¿s products.The complaint device was not available to be returned to the manufacturer for evaluation as it was discarded by the user facility.

Manufacturer Narrative

Plant investigation: the complaint sample was not returned to the manufacturer for physical evaluation, and the lot number was not provided.Therefore, the failure mode cannot be confirmed.A records review of the device manufacturing records could not be performed as the blood chamber lot number was not provided.However, a review of the production and quality control processes found no anomalies.All the involved personnel is duly trained and instrument calibration and machine maintenance status is in compliance.The investigation into the cause of the reported problem was not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

• Brand Name: CRIT-LINE III BLOOD CHAMBER II
• Type of Device: ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer (Section G): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 6545748
• MDR Text Key: 74471355
• Report Number: 2937457-2017-00325
• Device Sequence Number: 1
• Product Code: KOC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160749
• 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: 08/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 191058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 07/12/2017
• 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): Required Intervention