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 Dyspnea (1816); Low Blood Pressure/ Hypotension (1914); Dizziness (2194); 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 events of hypotension, dizziness, and shortness of breath (sob) exists.However, based on the lack of available information, potential causality cannot be established.The patient was admitted to the hospital with shortness of breath (sob), non-st segment elevation myocardial infarction (nonstemi), leg wound, diabetes, and fluid overload and a reported drop in blood pressure (bp), dizziness, and sob 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 shortness of breath (sob), non-st segment elevation myocardial infarction (nonstemi), leg wound, diabetes, and fluid overload.The patient underwent routine hemodialysis (hd) treatments while hospitalized.This event represents the first of three reported occurrences of hypotension, dizziness, and shortness of breath (sob) that were experienced by the patient while undergoing hemodialysis (hd) therapy.The event date is not known.Shortly after the hd treatment was initiated, the patient became hypotensive, dizzy, and short of breath.Unspecified labs were drawn with results appearing to indicate a "type b dialyzer reaction." the patient was treated with medications (not specified) and completed treatment.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 patient has since been discharged home (date unknown).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: 6545872
• MDR Text Key: 74472186
• Report Number: 2937457-2017-00326
• 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