MAUDE Adverse Event Report: B. BRAUN DOMINICAN REPUBLIC INC. BLOOD SETS WITH CARESITE INJECTION SITES; Y-TYPE BLOOD SET WITH FILTER & HAND PUMP

Catalog Number 354218

Device Problem Air Leak (1008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).One used y-type blood set, without packaging, was received for evaluation.One of the two y spikes on the set had a vented spike adapter attached.In an attempt to replicate the reported event, the returned set-up (with vented spike adapter still attached) was spiked and primed according to the instructions for use (ifu).The hand pump was squeezed several times to initiate flow.There were no air bubbles observed within the tubing line and the backcheck device below the filter chamber functioned as intended.Next, the vented spike adapter was removed, and the aforementioned simulation test was repeated.No air bubbles were observed within any location of the tubing set during testing.Furthermore, the set was subjected to occlusion and air pressure (leakage) testing according to specification with acceptable results.In addition, the reporting facility returned several photos depicting the series of events.Based on the photos, an empty tylenol bottle was inverted and spiked into the set.A minimal amount of fluid was observed in the filter chamber.A series of photos then depicted a decreasing amount of fluid in the hand pump.The final photo depicted air bubbles in the line below the hand pump.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or nonconformances of this nature.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number or lot number.Based on the results of this investigation, no specific conclusions can be made regarding the cause of the reported event.The returned sample met requirements according to specification, and the reported failure could not be reproduced.If the lactated ringers line is clamped off, as was indicated in the reported event summary, then air will draw into the line from the empty tylenol bottle.If additional pertinent information becomes available, a follow-up report will be filed.

Event Description

As reported by the user facility: event # 1: reports when the clinicians squeezed the hand pump of the blood tubing set to give fluids, the ball that sits under the filter chamber moved.Air then got into the tubing line.In one case, the line below the chamber had approximately 18 inches of air in it.Per follow-up correspondence with the reporting facility, the reporter clarified there was no blood running in the sets at the time the situations occurred.The anesthetists require the blood tubing sets for all general surgeries.This is done in case a patient does need blood, then the tubing is already in place.Lactated ringers (lr) solution is run through one side of the tubing, and antibiotics / pain meds are run through the other side.When antibiotics or pain meds are running, the lr side is clamped off, otherwise the lr will backflow into the medication.The reporter further stated that when administering tylenol pain meds they need to use a vented spike adapter.If the clinician is not paying close attention to when the tylenol is finished infusing, air will draw into the chamber and then into the line.If the nurse or crna becomes busy with a patient, this could be a very serious problem.The clinicians do keep an eye on the iv fluids, but in a trauma situation or if the clinician is busy attending to an unstable patient, and don't shut the tubing off with the spike adapter, the line will fill with air and could be a life threatening situation.This issue has occurred three different times -- two times using a vented spike adapter and one time without a vented spike adapter.There was no patient injury reported.

• Brand Name: BLOOD SETS WITH CARESITE INJECTION SITES
• Type of Device: Y-TYPE BLOOD SET WITH FILTER & HAND PUMP
• Manufacturer (Section D): B. BRAUN DOMINICAN REPUBLIC INC.; las americas industrial park; km22 autopista las americas; santo domingo, dominican republic ; DR
• Manufacturer Contact: eric roden ; las americas industrial park; km22 autopista las americas; santo domingo, dominican republic ; DR ; 5491000
• MDR Report Key: 5503509
• MDR Text Key: 40793114
• Report Number: 9614279-2016-00006
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K840212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 354218
• Device Lot Number: 0061458819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2016
• Initial Date FDA Received: 03/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2015
• 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