MAUDE Adverse Event Report: B. BRAUN DOMINICAN REPUBLIC INC. BLOOD ADMINISTRATION SET; SET, ADMINISTRATION, INTRA

Catalog Number 354218

Device Problem Fluid/Blood Leak (1250)

Patient Problems Cardiopulmonary Arrest (1765); Death (1802); Hemorrhage/Bleeding (1888); High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Blood Loss (2597)

Event Date 09/13/2016

Event Type  Death  

Manufacturer Narrative

This report has been identified as b.Braun medical inc.(bbmi) internal report # (b)(4).A representative from bbmi is attempting to obtain the lot number and additional details from the reporting facility regarding this case.One used y-type blood set, without packaging, was received for evaluation.The set was heavily contaminated and filled with blood.There was also hardened, dry blood observed on the outer end of the top cap of the pump housing assembly.The set was subjected to leakage testing according to specification.During this testing, leakage was identified at the top cap of the blood pump housing assembly.Further sample investigation is ongoing at this time.No adverse quality trends of this nature were identified during the complaint review process for the reported product catalog number.Without the lot number, a batch record review could not be performed.The investigation into this reported event is ongoing.A follow-up report will be submitted when the results of the investigation are available.

Event Description

As reported by the user facility: reports a leaking blood set resulting in blood infusion interruption.The set leaked at the hand pump section during a critical blood infusion.Blood spilled out rapidly and a unit of blood was wasted.The product was removed and two other sets were attempted to be started, but had the same issue.Patient impression provided by the reporting facility: [patient] was a (b)(6) female who presented to (b)(6) hospital with evidence of gastrointestinal bleed, with initial esophagogastroduodenoscopy unremarkable.Patient, during hospital stay, however, with recurrent hematochezia and hematemesis, requiring transfusion of a total of 6 units of prbcs.Tagged red cell scan was negative for any acute hemorrhaging.Eventual cta in the end did reveal active gastric hemorrhaging.Hypertension, with hypotensive episodes during the hospital stay, likely associated with acute blood loss, requiring icu care with pressors.Acute kidney injury, likely associated with gastrointestinal bleed, which briefly improved following iv fluid hydration.Cardiopulmonary arrest with no aggressive resuscitation efforts given patient's dnr status.The patient passed at 0235 on (b)(6) 2016.

Manufacturer Narrative

(b)(4).One used y-type blood set, without packaging was received for evaluation.The set was subjected to leakage testing per the specification.During this testing, leakage was identified at the top cap of the blood pump housing assembly.The defect appeared to be a result of insufficient solvent in one segment of the joint and/or a combination of the cap not being seated correctly on the tubing due to irregular tubing cut or inadequate insertion depth.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number or lot number.However, as a result of this occurrence, specifications will be updated to include irregular tubing cut characteristic during incoming inspection and also include uniform insertion of the tubing during manufacturing of the subassembly.The drawing will be modified to change the depth length and a new hand pump test will be developed for qc inspection.In addition, a formal awareness training session was conducted with all applicable personnel involved in the assembly and inspection of this product.The purpose of this training was to review the reported incident and to ensure all personnel understand and comply with the established assembly and inspection methods.Review of the discrepancy management system database and the device history records performed for the reported lot number did not reveal any abnormalities or nonconformances of this nature.If additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: BLOOD ADMINISTRATION SET
• Type of Device: SET, ADMINISTRATION, INTRA
• 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: 6027303
• MDR Text Key: 57367906
• Report Number: 9614279-2016-00070
• 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,Followup
• Report Date: 10/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/11/2019
• Device Catalogue Number: 354218
• Device Lot Number: 00VL501294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2016
• 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
• Patient Outcome(s): Death
• Patient Age: 93 YR
• Patient Weight: 69