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

Catalog Number 03-2722-9

Device Problems Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)

Patient Problems Chest Pain (1776); Blood Loss (2597)

Event Date 06/02/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The reported complaint was not confirmed as the complaint device was not available for manufacturer evaluation.As such, a definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.A records review was performed on the reported lot.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances identified during the manufacturing process which could be associated with the reported event.In addition, the batch record review confirmed the labeling, material, and process controls were within specification.The lot passed all release criteria.Review of the batch production record (bpr) did not reveal a probable cause for the customer complaint.

Event Description

A user facility's registered nurse reported that a patient experienced blood loss while undergoing hemodialysis (hd) treatment on a 2008t hd machine.The following details were provided.The patient experienced blood loss 42 minutes into a 3 hour 15 minute treatment.The connection between the venous fistula needle line and the combi set hemodialysis bloodline was cross threaded, resulting in an estimated blood loss of 500 milliliters (ml).The nurse untwisted and reconnect the line to stop the leak.The patient had chest pains and was lethargic.A 600 ml saline bolus was given for the chest pain.The chest pain subsided.No transfusion was needed.Treatment was discontinued and the patient was transferred to the hospital for the reported chest pain.The patient was evaluated and discharged; not admitted.The patient has recovered.No malfunction of the 2008k hd machine was observed or identified, prior to, during, or following the hd treatment.There was no allegations that a dialyzer malfunction occurred.The combi set hemodialysis bloodline was not available to be returned to the manufacturer for evaluation.

Manufacturer Narrative

Clinical investigation: a clinical investigation was performed by a specialist to identify a causal relationship between the combi set bloodline and the adverse event.The clinician concluded that the blood loss was a direct result of the patient¿s dialysis venous access needle (wingeater safety needle) and the combi set line being cross threaded at the connection which compromised the integrity of the closed system resulting in a blood leak.

• Brand Name: CUSTOM COMBI SET
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 6711485
• MDR Text Key: 79966008
• Report Number: 8030665-2017-00441
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 00840861100293
• UDI-Public: 00840861100293
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 03-2722-9
• Device Lot Number: 17BR01281
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 07/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2017
• 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; FRESENIUS NORMAL SALINE 1 LITER; FRESENIUS OPTIFLUX F180 DIALYZER; JMS WINGEATER SAFETY AV FISTULA NEEDLE SET
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Weight: 85