MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. FMC BLOODLINE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Catalog Number UNKNOWN- FMC BLOODLINE

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Blood Loss (2597); Hypervolemia (2664)

Event Date 12/19/2018

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: the patient blood loss with subsequent transfer to the er was a direct result of the patient¿s venous needle dislodgement (not a fresenius product).There is no documentation in the complaint file that shows a causal relationship between the fmc bloodlines and the adverse event.There is no allegation of a malfunction or deficiency related to any fresenius product(s).It is unknown what occurred to cause the needle dislodgement with blood loss approximately 2 hours into the 4 hour hd treatment.Any fresenius product can be excluded as the cause of the event.

Event Description

On (b)(6) 2019 a voluntary medwatch was received from a hemodialysis (hd) center documenting a needle dislodgement (not a fresenius product) during hd treatment.This (b)(6) female arrived alert and oriented to a scheduled hd treatment (time unknown) on (b)(6) 2018 with pre-dialysis vital signs of blood pressure (bp) 187/62, pulse 72, respirations 18 and temperature 98.0.At 19:59 hours the patient was observed with access uncovered and no bleeding from the site.At 20:01 hours, approximately 2.5 hours into the 4 hour treatment a 30 minute vital sign check was conducted and it was documented that the patient was noted to be slow to respond.Vitals at this time were bp 47/26, pulse 64.The patient¿s venous needle was dislodged with the tape intact on the wings of the needle.A large amount of blood was then observed on the chair and floor.The estimated blood loss (ebl) was 500ml.The venous line was clamped and pressure was applied to the cannulation site.1000ml normal saline (ns) was administered to the patient via the arterial needle and 911 was called.After the infusion of ns the patient was alert and orientated with bp 110/50, pulse 67, resp 18.The patient was transported via emergency medical services (ems) to the hospital where the patient was admitted.Hospital course is unknown and discharge date is unknown.The patient returned for regularly scheduled hd treatment on (b)(6) 2018 with no further issues reported.

Manufacturer Narrative

Plant investigation: the sample was not returned to the manufacturer and the lot number was not provided.A manufacturing review was performed on the products shipped to the patient for the three (3) month time frame which immediately preceded the event occurrence date.This review included the lot numbers for all fresenius bloodlines shipped to this account within the selected time frame.The entire set of lots have been sold and distributed.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.An investigation of the device history records (dhr) was conducted and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The product lots involved met all specifications for release.A review of the dhr did not reveal a probable cause for the customer complaint.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.

• Brand Name: FMC BLOODLINE
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• MDR Report Key: 8377287
• MDR Text Key: 137365746
• Report Number: 8030665-2019-00369
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• PMA/PMN Number: K962081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN- FMC BLOODLINE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 03/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS HEMODIALYSIS MACHINE; FRESENIUS HEMODIALYSIS MACHINE
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 88