MAUDE Adverse Event Report: REYNOSA PLANT CUSTO COMBI SET

Catalog Number 03-2722-9

Device Problem Disconnection (1171)

Patient Problems Atrial Tachycardia (1731); Low Blood Pressure/ Hypotension (1914); Diaphoresis (2452); Blood Loss (2597)

Event Date 07/10/2014

Event Type  Injury  

Event Description

A hemodialysis inpatient user facility reported that approximately 19 minutes into treatment, a blood leak occurred.The bloodline leak was visually observed and the rn immediately clamped the lines, blood was returned to pt and normal saline bolus was started.The pt became tachycardic and hypotensive.The pt recalls feeling dyspneic and having some chest tightness and he was diaphoretic.The pt initially was lethargic, but not unconscious.His blood pressure was 58/30 and heart rate was 44.The pt was given 3 liters of normal saline.The pt had been given heparin sodium (porcine) prior to the start of treatment.Upon discharge from the facility, the pt was alert and oriented, blood pressure was 106/61 and heart rate was 65.Pre-incident hct was 39 ((b)(6) 2014), post-incident hct was 24.6 ((b)(6) 2014).Pt was transported to emergency where he was admitted due to the substantial blood loss.Per hospital summary, the pt was alert and able to answer questions.He had dyspnea immediately after the blood loss and then denies any further dyspnea, had regular heart rate rhythm without a gallop.There were no anginal symptoms.His blood pressure was 97/59 and heart rate was 61.The pt tolerated dialysis the following day and was discharged form the hospital.The pt did not require a blood transfusion.(b)(4).

Manufacturer Narrative

Medical records were provided and reviewed.Based on the 30 pages of medical records information and a review of the documentation in the fresenius pilgrim system, it appears that on (b)(6) 2014, while receiving hemodialysis, there was a leak in the combi set tubing, resulting in the pt not being able to complete his treatment, blood loss, hypotension, tachycardia and admission to the hospital.He experienced a drop in his hematocrit from 39 to 24.6.The pt was discharged from the hospital the following day.A return sample kit was sent to the clinic so the tubing can be evaluated.No sample has been returned.The combi set tubing can be evaluated.No sample has been returned.The combi set tubing will also be evaluated against similar lot numbers and dates.This event is being filed as a mdr reportable serious injury to comply with our regulatory commitment to report any serious injury while using a fresenius device.Plant investigation has not yet been completed.A follow up report will be filed upon completion of the investigation.

• Brand Name: CUSTO COMBI SET
• Manufacturer (Section D): REYNOSA PLANT; reynosa ; MX
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; 1331 parque industrial; reynosa, tamaulipas CP 8 8780; MX CP 88780
• Manufacturer Contact: dianne chin ; 920 winter street; waltham, MA 02451-1457 ; 7816999105
• MDR Report Key: 4293621
• MDR Text Key: 5192350
• Report Number: 8030665-2014-00594
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2017
• Device Catalogue Number: 03-2722-9
• Device Lot Number: 14ER01123
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2014
• 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 2008T HEMODIALYSIS MACHINE
• Patient Outcome(s): Hospitalization
• Patient Age: 60 YR
• Patient Weight: 103