MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA PATIENT CONNECTOR CLIP (NON-STERILE)

Catalog Number 04-9100-1

Device Problems Disconnection (1171); Connection Problem (2900)

Patient Problems Cardiac Arrest (1762); Death (1802); Blood Loss (2597)

Event Date 10/14/2014

Event Type  Death  

Event Description

According to a facility medwatch received, a pt with acute renal failure was receiving an in-patient hemodialysis treatment.This pt was admitted to the hospital for an appendectomy and ended up with an open bowel resection on an unk date.The pt had "just been transferred from the icu the previous day" where "he had been on the ventilator." blood was found leaking from the venous limb of the catheter and was initially reported to be estimated at 100cc of blood.The pt's blood pressure was stable; however, his heart rate began to drop and he "coded".The pt subsequently expired.The sample was discarded but a companion sample is available for mfr review.(b)(4).

Manufacturer Narrative

According to the treating registered nurse (rn) upon follow up, the pt did not appear to "be himself" prior to hemodialysis.He verbalized vague complaints and asked for the treatment to be stopped.The nurse practitioner was consulted after a "bruit" was heard over the right abdomen.The rn confirmed the info as reported in the facility medwatch and added, with 40 minutes left in the treatment, the md gave orders to use the pt's hemodialysis catheter in his right chest.This catheter had not been used recently.The rn stated she disconnected the blood lines from the fistula needles and connected to the catheter.There was no issue with the venous line when connected to the fistula needles but it appeared "smaller" than the catheter opening.She stated she did not remember connecting the hemoclip; therefore, it is unk if it was connected according to the instructions for use.She states she left the pt's bedside and was gone approx 5 minutes.When she returned, she noticed blood on the pt's gown and the blood line had loosened from the catheter.She also noted the hemoclip at the time and it also appeared to be loose.The line was re-secured.Normal saline solution was administered without leak noted.Blood pressure remained stable but heart rate began to drop.She reports blood loss was hard to estimate but reported as 100ml.Pt coded and expired at 12:55 pm.The treatment sheet provided was reviewed.The treatment began at 8:48 am.The pt complained of abdominal pain.One unit of packed red blood cells was transfused at 10:30 am.Anti-nausea medicine was given at 11:00 am.The pt had a nasogastric tube in place.Based on the info provided, it is unk how the device may have caused or contributed to the event.The post market clinical dept is in the process of requesting pt medical records and treatment data info regarding the reported expiration.A supplemental medwatch report will be submitted upon completion of the investigation.

• Brand Name: PATIENT CONNECTOR CLIP (NON-STERILE)
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; reynosa ; MX
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen 1331; parque industrial; reynosa
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter st; waltham, MA 02451 ; 8006621237
• MDR Report Key: 4300436
• MDR Text Key: 5059679
• Report Number: 8030665-2014-00899
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001875
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2016
• Device Catalogue Number: 04-9100-1
• Device Lot Number: 14DR06008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2014
• 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: TO EVENT; ZOFRAN IV; BLOOD TRANSFUSION OF 1 UNIT PACKED CELLS PRIOR; FRESENIUS COMBISET
• Patient Outcome(s): Death
• Patient Age: 80 YR
• Patient Weight: 77